Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Arm IA

Arm IA (docetaxel, cyclophosphamide)

ACTIVE_COMPARATOR

EXPERIMENTAL

Drug: docetaxel

Other: laboratory biomarker analysis

Arm IB

Arm IB (doxorubicin hydrochloride, cyclophosphamide)

ACTIVE_COMPARATOR

EXPERIMENTAL

Arm IIA

Arm IIA (docetaxel, cyclophosphamide, trastuzumab)

Drug: cyclophosphamide

Other: laboratory biomarker analysis

Arm IIB

Arm IIB (chemotherapy, trastuzumab)

BIOLOGICAL

DRUG

trastuzumab

doxorubicin hydrochloride

Arm IIA

Arm IB (doxorubicin hydrochloride, cyclophosphamide)

Arm IIB

Arm IIB (chemotherapy, trastuzumab)

cyclophosphamide

docetaxel

Arm IA

Arm IA (docetaxel, cyclophosphamide)

Arm IB

Arm IIA (docetaxel, cyclophosphamide, trastuzumab)

docetaxel

cyclophosphamide

Arm IA

Arm IA (docetaxel, cyclophosphamide)

Arm IIA

Arm IB (doxorubicin hydrochloride, cyclophosphamide)

DRUG

BIOLOGICAL

doxorubicin hydrochloride

trastuzumab

Arm IB

Arm IIA (docetaxel, cyclophosphamide, trastuzumab)

Arm IIB

Arm IIB (chemotherapy, trastuzumab)

Arm IB

Arm IB (doxorubicin hydrochloride, cyclophosphamide)

Arm IIB

Arm IIB (chemotherapy, trastuzumab)

<p>DISEASE CHARACTERISTICS:</p><ul><li>The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination</li><li><p>All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met:</p><ul><li>By pathologic evaluation, primary tumor must be pT1-3</li><li><p>By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b</p><ul><li><p>If pN0, one of the following criteria must be met:</p><ul><li>pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative</li><li>pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of ≥ 25</li><li>pT3 regardless of hormone-receptor status, histologic grade, and Oncotype DX® Recurrence Score</li></ul></li></ul></li></ul></li><li>No T4 tumors including inflammatory breast cancer</li><li><p>No definitive clinical or radiologic evidence of metastatic disease</p><ul><li>NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization</li></ul></li><li>No synchronous or previous contralateral invasive breast cancer (patients with synchronous and&#x2F;or previous contralateral DCIS or LCIS are eligible)</li><li>No previous ipsilateral invasive breast cancer or ipsilateral DCIS (patients with synchronous or previous ipsilateral LCIS are eligible)</li><li><p>HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low as defined below:</p><ul><li>IHC must be performed and the IHC staining results must indicate a score of 1+ (in situ hybridization [ISH] testing is not required) or 2+ (ISH must also be performed and must indicate that the tumor is HER2-low as described below)</li><li><p>If ISH (FISH or CISH) testing is performed, test results must be as follows and IHC must be 1+ or 2+:</p><ul><li>If FISH is performed, the ratio of HER2 to CEP17 must be &lt; 2.0 or, if a ratio was not performed, the HER2 gene copy number must be &lt; 4 per nucleus</li><li>If CISH is performed, the result must indicate a HER2 gene copy number of &lt; 4 per nucleus</li></ul></li><li>NOTE: If the IHC staining intensity is reported as a range, e.g., 0 to 1+ or 1+ to 2+, the higher intensity score in the range should be used to determine eligibility.</li></ul></li><li><p>No primary tumor with any of the following HER2 testing results:</p><ul><li><p>IHC staining intensity:</p><ul><li>0 on all evaluations of specimens</li><li>3+ on evaluation of any specimen</li></ul></li><li>ISH with a ratio of HER2 to CEP17 ≥ 2.0 on evaluation of any specimen</li><li>ISH result indicating HER2 gene copy number ≥ 4 per nucleus on evaluation of any specimen</li></ul></li><li><p>The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy) (patients who have had a nipple-sparing mastectomy are eligible)</p><ul><li>For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible (patients with margins positive for LCIS are eligible without additional resection)</li><li>For patients who undergo mastectomy, margins must be free of gross residual tumor (patients with microscopic positive margins are eligible as long as post-mastectomy RT of the chest wall will be administered)</li><li>The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days</li></ul></li><li><p>The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below:</p><ul><li><p>Sentinel lymphadenectomy alone:</p><ul><li>If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b</li><li>If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a, the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes</li></ul></li><li>Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive</li><li>Axillary lymphadenectomy with or without SN isolation procedures</li></ul></li><li>The patient must have ER analysis performed on the primary tumor prior to randomization; if ER analysis is negative, then PgR analysis must also be performed (either the core biopsy or surgical resection specimen can be used for ER&#x2F;PgR testing); patients with a primary tumor that is hormone receptor-positive or receptor-negative are eligible</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li>Pre- or postmenopausal</li><li>ECOG performance status of 0 or 1</li><li>ANC must be ≥ 1,200&#x2F;mm^3</li><li>Platelet count must be ≥ 100,000&#x2F;mm^3</li><li>Hemoglobin must be ≥ 10 g&#x2F;dL</li><li>Total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation &gt; ULN to 1.5 x ULN due to Gilbert disease or similar syndrome involving slow conjugation of bilirubin</li><li>Alkaline phosphatase must be ≤ 2.5 x ULN for the lab</li><li>AST must be ≤ 1.5 x ULN for the lab (if ALT is performed instead of AST [per institution&#x27;s standard practice], the ALT value must be ≤ 1.5 x ULN; if both were performed, the AST must be ≤ 1.5 x ULN)</li><li>Alkaline phosphatase and AST may not both be &gt; the ULN</li><li>Patients with AST or alkaline phosphatase &gt; ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the above requirements are met</li><li>Patients with alkaline phosphatase that is &gt; ULN but ≤ 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease</li><li>The most recent postoperative serum creatinine performed within 6 weeks prior to randomization must be ≤ ULN for the lab</li><li>Not pregnant or nursing</li><li>Negative pregnancy test</li><li><p>LVEF assessment must be performed within 90 days prior to randomization; LVEF assessment performed by 2-D echocardiogram is preferred, however, MUGA scan may be substituted based on institutional preferences</p><ul><li>For patients who will receive the TC chemotherapy regimen, the LVEF must be ≥ 50% regardless of the cardiac-imaging facility&#x27;s lower limit of normal</li><li>For patients who will receive the AC→WP chemotherapy regimen, the LVEF must be ≥ 55% regardless of the cardiac-imaging facility&#x27;s lower limit of normal</li><li>NOTE: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments, it is critical that this baseline study be an accurate assessment.
If the baseline LVEF is &gt; 70%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and repeat the test if the accuracy is uncertain.</li></ul></li><li>No history of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization</li><li><p>No cardiac disease (history of and&#x2F;or active disease) that would preclude the use of the drugs included in the treatment regimens, including, but not limited to:</p><ul><li><p>Active cardiac disease:</p><ul><li>Angina pectoris that requires the current use of anti-anginal medication</li><li>Ventricular arrhythmias except for benign premature ventricular contractions</li><li>Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication</li><li>Conduction abnormality requiring a pacemaker</li><li>Valvular disease with documented compromise in cardiac function</li><li>Symptomatic pericarditis</li></ul></li><li><p>History of cardiac disease:</p><ul><li>Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function</li><li>History of documented CHF</li><li>Documented cardiomyopathy</li></ul></li></ul></li><li><p>No hypertension defined according to the following ineligibility criteria:</p><ul><li>For patients who will receive TC (regardless of the patient&#x27;s age): uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)</li><li>For patients &lt; 50 years old who will receive AC→WP: uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)</li><li>For patients ≥ 50 years old who will receive AC→WP: uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg OR controlled hypertension (systolic BP ≤ 150 mm Hg and diastolic BP ≤ 90 mm Hg), if anti-hypertensive medication(s) are needed</li><li>NOTE: Patients who are not eligible based on the AC→WP regimen BP criteria but who meet the TC regimen BP criteria are eligible for B-47 if the intended chemotherapy regimen is changed to TC.</li></ul></li><li>No active hepatitis B or hepatitis C with abnormal liver function tests</li><li>No intrinsic lung disease resulting in dyspnea</li><li>No poorly controlled diabetes mellitus</li><li>No active infection or chronic infection requiring chronic suppressive antibiotics</li><li>No nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ grade 2, per the CTCAE v4.0</li><li>No conditions that would prohibit administration of corticosteroids</li><li>No known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor® EL</li><li>No other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up</li><li>No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li>See Disease Characteristics</li><li>No previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy</li><li>No chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization</li><li>No whole-breast RT prior to randomization or partial-breast RT that cannot be completed on or before the date of randomization</li><li>No use of any investigational product within 30 days prior to randomization</li><li>No continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor (patients are eligible if these medications are discontinued prior to randomization)</li><li>No continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy (patients are eligible if these medications are discontinued prior to randomization)</li><li>No chronic daily treatment with corticosteroids with a dose of ≥ 10 mg&#x2F;day methylprednisolone equivalent (excluding inhaled steroids)</li><li>No other concurrent chemotherapy</li><li>No other concurrent targeted therapy for malignancy</li><li>No partial-breast irradiation following randomization</li><li>Concurrent participation in NSABP-B-39 allowed</li></ul>

<p>Inclusion Criteria:</p><ul><li>The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination</li><li><p>All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met:</p><ul><li>By pathologic evaluation, primary tumor must be pT1-3</li><li><p>By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b,pN1c), pN2a, pN2b, pN3a, or pN3b</p><ul><li><p>If pN0, one of the following criteria must be met:</p><ul><li>pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative</li><li>pT2 and ER positive (PgR status may be positive or negative) and either grade 3histology or Oncotype DX® Recurrence Score of ≥ 25; or</li><li>pT3 regardless of hormone receptor status, histologic grade, and Oncotype DX Recurrence Score</li></ul></li></ul></li></ul></li><li>No T4 tumors including inflammatory breast cancer</li><li><p>No definitive clinical or radiologic evidence of metastatic disease</p><ul><li>NOTE: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization</li></ul></li><li>No synchronous or previous contralateral invasive breast cancer (patients with synchronous and&#x2F;or previous contralateral DCIS or LCIS are eligible)</li><li>No previous ipsilateral invasive breast cancer or ipsilateral DCIS (patients with synchronous or previous ipsilateral LCIS are eligible)</li><li><p>HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2-low as defined below</p><ul><li>IHC must be performed and the IHC staining results must indicate a score of 1+ (in situ hybridization [ISH] testing is not required) or 2+ (ISH must also be performed and must indicate that the tumor is HER2-low as described below)</li><li>If ISH testing is performed, test results must be as follows and IHC must be 1+ or 2+: The ratio of HER2 to CEP17 must be &lt; 2.0 or, if a ratio was not performed, the HER2 gene copy number must be &lt; 4 per nucleus</li><li>Note: If the IHC staining intensity is reported as a range, e.g., 0 to 1+ or 1+ to 2+, the higher intensity score in the range should be used to determine eligibility</li></ul></li><li><p>No primary tumor with any of the following HER2 testing results:</p><ul><li><p>IHC staining intensity:</p><ul><li>0 on all evaluations of specimens</li><li>3+ on evaluation of any specimen</li></ul></li><li>ISH with a ratio of HER2 to CEP17 &gt;= 2.0 on evaluation of any specimen</li><li>ISH result indicating HER2 gene copy number &gt;= 4 per nucleus on evaluation of any specimen</li></ul></li><li><p>The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy) (patients who have had a nipple-sparing mastectomy are eligible)</p><ul><li>For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible (patients with margins positive for LCIS are eligible without additional resection)</li><li>For patients who undergo mastectomy, margins must be free of gross residual tumor(patients with microscopic positive margins are eligible as long as post-mastectomy RT of the chest wall will be administered)</li><li>The interval between the last surgery for breast cancer (treatment or staging) and randomization must be no more than 84 days</li></ul></li><li><p>The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below:</p><ul><li><p>Sentinel lymphadenectomy alone:</p><ul><li>If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b</li><li>If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a, the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes</li></ul></li><li>Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive</li><li>Axillary lymphadenectomy with or without SN isolation procedures</li></ul></li><li>The patient must have ER analysis performed on the primary tumor prior to randomization; if ER analysis is negative, then PgR analysis must also be performed (either the core biopsy or surgical resection specimen can be used for ER&#x2F;PgR testing); patients with a primary tumor that is hormone receptor-positive or receptor-negative are eligible</li><li>Pre- or postmenopausal</li><li>ECOG performance status of 0 or 1</li><li>ANC must be ≥ 1,200&#x2F;mm^3</li><li>Platelet count must be ≥ 100,000&#x2F;mm^3</li><li>Hemoglobin must be ≥ 10 g&#x2F;dL</li><li>Total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation &gt; ULN to 1.5 x ULN due to Gilbert disease or similar syndrome involving slow conjugation of bilirubin</li><li>Alkaline phosphatase must be ≤ 2.5 x ULN for the lab</li><li>AST must be ≤ 1.5 x ULN for the lab (if ALT is performed instead of AST [per institution&#x27;s standard practice], the ALT value must be ≤ 1.5 x ULN; if both were performed, the AST must be ≤ 1.5 x ULN)</li><li>Alkaline phosphatase and AST may not both be &gt; the ULN</li><li>Patients with AST or alkaline phosphatase &gt; ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the above requirements are met</li><li>Patients with alkaline phosphatase that is &gt; ULN but ≤ 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease</li><li>The most recent post operative serum creatinine performed within 6 weeks prior to randomization must be ≤ ULN for the lab</li><li>Not pregnant or nursing</li><li>Negative pregnancy test</li><li><p>LVEF assessment must be performed within 90 days prior to randomization; LVEF assessment performed by 2-D echo cardiogram is preferred, however, MUGA scan maybe substituted based on institutional preferences</p><ul><li>For patients who will receive the TC chemotherapy regimen, the LVEF must be≥ 50% regardless of the cardiac-imaging facility&#x27;s lower limit of normal</li><li>For patients who will receive the AC→WP chemotherapy regimen, the LVEF must be ≥ 55% regardless of the cardiac-imaging facility&#x27;s lower limit of normal</li><li>NOTE: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments, it is critical that this baseline study be an accurate assessment.
If the baseline LVEF is &gt; 70%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and repeat the test if the accuracy is uncertain.</li></ul></li><li>No history of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization</li><li><p>No cardiac disease (history of and&#x2F;or active disease) that would preclude the use of the drugs included in the treatment regimens, including, but not limited to:</p><ul><li><p>Active cardiac disease:</p><ul><li>Angina pectoris that requires the current use of anti-anginal medication</li><li>Ventricular arrhythmias except for benign premature ventricular contractions</li><li>Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication</li><li>Conduction abnormality requiring a pacemaker</li><li>Valvular disease with documented compromise in cardiac function</li><li>Symptomatic pericarditis</li></ul></li><li><p>History of cardiac disease:</p><ul><li>Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function</li><li>History of documented CHF</li><li>Documented cardiomyopathy</li></ul></li></ul></li><li><p>No hypertension defined according to the following ineligibility criteria:</p><ul><li>For patients who will receive TC (regardless of the patient&#x27;s age): uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)</li><li>For patients &lt; 50 years old who will receive AC→WP: uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)</li><li>For patients ≥ 50 years old who will receive AC→WP: uncontrolled hypertension defined as sustained systolic BP &gt; 150 mm Hg or diastolic BP &gt; 90 mm Hg OR controlled hypertension (systolic BP ≤ 150 mm Hg and diastolic BP ≤ 90 mmHg), if anti-hypertensive medication(s) are needed</li><li>NOTE: Patients who are not eligible based on the AC→WP regimen BP criteria but who meet the TC regimen BP criteria are eligible for B-47 if the intended chemotherapy regimen is changed to TC</li></ul></li><li>No active hepatitis B or hepatitis C with abnormal liver function tests</li><li>No intrinsic lung disease resulting in dyspnea</li><li>No poorly controlled diabetes mellitus</li><li>No active infection or chronic infection requiring chronic suppressive antibiotics</li><li>No nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ grade 2, per the CTCAE v4.0</li><li>No conditions that would prohibit administration of corticosteroids</li><li>No known hypersensitivity to any of the study drugs or excipients, e.g., polysorbate 80 and Cremophor® EL</li><li>No other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up</li><li>No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements</li><li>Concurrent participation in NSABP-B-39 allowed</li><li>No previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy</li><li>No chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer prior to randomization</li><li>No whole-breast RT prior to randomization or partial-breast RT that cannot be completed on or before the date of randomization</li><li>No use of any investigational product within 30 days prior to randomization</li><li>No continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor (patients are eligible if these medications are discontinued prior to randomization)</li><li>No continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy (patients are eligible if these medications are discontinued prior to randomization)</li><li>No chronic daily treatment with corticosteroids with a dose of ≥ 10 mg&#x2F;day methylprednisol one equivalent (excluding inhaled steroids)</li><li>No other concurrent chemotherapy</li><li>No other concurrent targeted therapy for malignancy</li><li>No partial-breast irradiation following randomization</li></ul>

Recurrence-free interval

Recurrence-free interval (RFI)

Distant recurrence-free interval

Distant recurrence-free interval (DRFI)

Louis Fehrenbacher, MD

Louis Fehrenbacher

Kaiser Permanente Medical Center - Vallejo

NSABP Foundation Inc

Regional Medical Center

Northeast Alabama Regional Medical Center

36207

36202

256-235-5877

256-235-5084

Providence Cancer Center

Providence Hospital

RECRUITING

ACTIVE_NOT_RECRUITING

Anchorage

Mobile

Alaska

Alabama

99508

36608

61.21806

30.69436

-149.90028

-88.04305

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Providence Alaska Medical Center

Fairbanks

Anchorage

99701

99508

Craig R. Nichols, MD

Jeanne E. Anderson

503-494-6346

907-261-3109

64.83778

61.21806

-147.71639

-149.90028

Premiere Oncology of Arizona

Fairbanks Memorial Hospital

Scottsdale

Fairbanks

Arizona

Alaska

85258

99701

Giraldo (Gerry) Kato

Craig R. Nichols

480-860-5000

503-215-6412

33.50921

64.83778

-111.89903

-147.71639

NEA Medical Clinic - East Matthews

Premiere Oncology of Arizona

Jonesboro

Scottsdale

Arkansas

Arizona

72401

85258

Carroll D. Scroggin, MD

Giraldo (Gerry) Kato

870-934-5343

480-860-5000

35.8423

33.50921

-90.70428

-111.89903

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

NEA Medical Center

RECRUITING

TERMINATED

Little Rock

Jonesboro

72205

72401

34.74648

35.8423

-92.28959

-90.70428

Kaiser Permanente Medical Center - Anaheim/Orange County

Northeast Arkansas Clinic

Anaheim

Jonesboro

California

Arkansas

92807

72401

Jonathan A. Polikoff, MD

Carroll D. Scroggin

619-528-5888

501-686-8274

33.83529

35.8423

-117.9145

-90.70428

Kaiser Permanente - Deer Valley

University of Arkansas for Medical Sciences

Antioch

Little Rock

California

Arkansas

94531

72205

Louis Fehrenbacher, MD

V. Suzanne Klimberg

707-651-2577

501-686-8274

38.00492

34.74648

-121.80579

-92.28959

Kaiser Permanente Medical Center - Baldwin Park

Kaiser Anaheim Medical Center

Baldwin Park

Anaheim

91706

92807

Jonathan A. Polikoff, MD

Jonathan A. Polikoff

619-528-5888

626-564-3455

34.08529

33.83529

-117.9609

-117.9145

Kaiser Permanente Medical Center - Bellflower

Kaiser Permanente-Deer Valley Medical Center

Bellflower

Antioch

90706

94531

Jonathan A. Polikoff, MD

Louis Fehrenbacher

619-528-5888

626-564-3455

33.88168

38.00492

-118.11701

-121.80579

Alta Bates Summit Comprehensive Cancer Center

Kaiser Permanente Medical Group - Baldwin Park

Berkeley

Baldwin Park

94704

91706

Clinical Trials Office - Alta Bates Summit Comprehensive Cance

Jonathan A. Polikoff

510-204-3428

626-564-3455

37.87159

34.08529

-122.27275

-117.9609

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Kaiser Foundation Hospital

Burbank

Bellflower

91505

90706

Clinical Trials Office - Providence Saint Joseph Medical Cente

Jonathan A. Polikoff

818-847-3220

626-564-3455

34.18084

33.88168

-118.30897

-118.11701

Peninsula Medical Center

Alta Bates Summit Medical Center-Herrick Campus

Burlingame

Berkeley

94010

94704

David H. Irwin, MD

David H. Irwin

510-204-1591

510-204-3428

37.5841

37.87159

-122.36608

-122.27275

East Bay Radiation Oncology Center

Providence Saint Joseph Medical Center

Castro Valley

Burbank

94546

91505

James H. Feusner, MD

Raul R. Mena

510-428-3689

818-847-3220

37.6941

34.18084

-122.08635

-118.30897

Valley Medical Oncology Consultants - Castro Valley

Roy and Patricia Disney Family Cancer Center

Castro Valley

Burbank

94546

91505

James H. Feusner, MD

Raul R. Mena

510-428-3689

818-847-3220

37.6941

34.18084

-122.08635

-118.30897

Cancer Care Center at John Muir Health - Concord Campus

Mills - Peninsula Hospitals

Concord

Burlingame

94524-4110

94010

Clinical Trials Office - Cancer Care Center at John Muir Healt

David H. Irwin

925-674-2580

510-204-3428

37.97798

37.5841

-122.03107

-122.36608

North Bay Cancer Center

East Bay Radiation Oncology Center

Fairfield

Castro Valley

94533

94546

Clinical Trials Office - North Bay Cancer Center

James H. Feusner

707-429-6976

510-450-7600

38.24936

37.6941

-122.03997

-122.08635

Kaiser Permanente Medical Center - Fontana

Valley Medical Oncology Consultants-Castro Valley

Fontana

Castro Valley

92335

94546

Jonathan A. Polikoff, MD

James H. Feusner

619-528-5888

510-450-7600

34.09223

37.6941

-117.43505

-122.08635

Kaiser Permanente - Fremont

John Muir Medical Center-Concord Campus

Fremont

Concord

94538

94520

Louis Fehrenbacher, MD

Elizabeth A. Odumakinde

707-651-2577

925-674-2580

37.54827

37.97798

-121.98857

-122.03107

Valley Medical Oncology

Northbay Cancer Center

Fremont

Fairfield

94538

94533

James H. Feusner, MD

Brian G. Vikstrom

510-428-3689

707-429-6976

37.54827

38.24936

-121.98857

-122.03997

Kaiser Permanente Fresno Medical Center

Kaiser Permanente Hospital

Fresno

Fontana

93720

92335

Louis Fehrenbacher, MD

Jonathan A. Polikoff

707-651-2577

626-564-3455

36.74773

34.09223

-119.77237

-117.43505

Glendale Memorial Hospital Comprehensive Cancer Center

Kaiser Permanente, Fremont

Glendale

Fremont

91204

94538

Clinical Trials Office - Glendale Memorial Hospital Comprehens

Louis Fehrenbacher

818-409-7653

626-564-3455

34.14251

37.54827

-118.25508

-121.98857

California Cancer Care, Incorporated - Greenbrae

Valley Medical Oncology Consultants-Fremont

Greenbrae

Fremont

94904

94538

Peter D. Eisenberg, MD

James H. Feusner

415-925-5000

510-450-7600

37.94854

37.54827

-122.5247

-121.98857

Kaiser Permanente Medical Center - Harbor City

Kaiser Permanente

Harbor City

Fresno

90710

93720

Jonathan A. Polikoff, MD

Louis Fehrenbacher

619-528-5888

626-564-3455

33.79002

36.74773

-118.29785

-119.77237

Kaiser Permanente Medical Center - Hayward

Glendale Memorial Hospital and Health Center

Hayward

Glendale

94545

91204

Louis Fehrenbacher, MD

Ghassan Al-Jazayrly

707-651-2577

818-409-7653

37.66882

34.14251

-122.0808

-118.25508

Kaiser Permanente - Irvine

Marin Cancer Care Inc

Irvine

Greenbrae

92618

94904

Jonathan A. Polikoff, MD

Peter D. Eisenberg

619-528-5888

415-925-5000

33.66946

37.94854

-117.82311

-122.5247

Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

Sutter Health Western Division Cancer Research Group

Long Beach

Greenbrae

90806

94904

Clinical Trials Office - Breastlink Medical Group, Incorporate

David H. Irwin

562-981-6101

510-204-3428

33.76696

37.94854

-118.18923

-122.5247

Todd Cancer Institute at Long Beach Memorial Medical Center

Kaiser Permanente - Harbor City

Long Beach

Harbor City

90806

90710

Bichlien Nguyen

Jonathan A. Polikoff

562-933-0900

626-564-3455

33.76696

33.79002

-118.18923

-118.29785

Kaiser Permanente Medical Center - Los Angeles

Kaiser Permanente, Hayward

Los Angeles

Hayward

90027

94545

Jonathan A. Polikoff, MD

Louis Fehrenbacher

619-528-5888

626-564-3455

34.05223

37.66882

-118.24368

-122.0808

Kaiser Foundation Hospital - West Los Angeles

Southern California Permanente Medical Group

Los Angeles

Irvine

90034

92618

Jonathan A. Polikoff, MD

Jonathan A. Polikoff

619-528-5888

626-564-3455

34.05223

33.66946

-118.24368

-117.82311

Contra Costa Regional Medical Center

Breastlink Medical Group Inc

Martinez

Long Beach

94553-3156

90806

James H. Feusner, MD

James R. Waisman

510-428-3689

562-981-6101

38.01937

33.76696

-122.13413

-118.18923

Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

Long Beach Memorial Medical Center-Todd Cancer Institute

Monterey

Long Beach

93940

90806

Thomas P. Bradley, MD, PhD, FACP

Bichlien Nguyen

831-375-4777

562-933-0900

36.60024

33.76696

-121.89468

-118.18923

Camino Medical Group - Treatment Center

Kaiser Permanente Los Angeles Medical Center

Mountain View

Los Angeles

94040

90027

Peter P. Yu, MD

Jonathan A. Polikoff

408-524-5814

626-564-3455

37.38605

34.05223

-122.08385

-118.24368

El Camino Hospital Cancer Center

Kaiser Permanente

RECRUITING

WITHDRAWN

Mountain View

Los Angeles

94040

90027

37.38605

34.05223

-122.08385

-118.24368

Sutter Health - Western Division Cancer Research Group

Kaiser Permanente-West Los Angeles

Novato

Los Angeles

94945

90034

David H. Irwin, MD

Jonathan A. Polikoff

510-204-1591

626-564-3455

38.10742

34.05223

-122.5697

-118.24368

Highland General Hospital

Contra Costa Regional Medical Center

Oakland

Martinez

94602

94553-3156

James H. Feusner, MD

James H. Feusner

510-428-3689

510-450-7600

37.80437

38.01937

-122.2708

-122.13413

Alta Bates Summit Medical Center - Summit Campus

Community Hospital of Monterey Peninsula

Oakland

Monterey

94609

93940

Clinical Trials Office - Alta Bates Summit Medical Center - Su

Thomas P. Bradley

510-204-1414

831-625-4753

37.80437

36.60024

-122.2708

-121.89468

Bay Area Breast Surgeons, Incorporated

El Camino Hospital

Oakland

Mountain View

94609

94040

James H. Feusner, MD

James H. Feusner

510-428-3689

510-450-7600

37.80437

37.38605

-122.2708

-122.08385

CCOP - Bay Area Tumor Institute

Palo Alto Medical Foundation-Camino Division

Oakland

Mountain View

94609

94040

James H. Feusner, MD

Peter P. Yu

510-428-3689

650-934-7000

37.80437

37.38605

-122.2708

-122.08385

Larry G Strieff MD Medical Corporation

Highland General Hospital

94609

94602

James H. Feusner, MD

James H. Feusner

510-428-3689

510-450-7600

Tom K Lee, Incorporated

Alta Bates Summit Medical Center - Summit Campus

James H. Feusner, MD

James H. Feusner

510-428-3689

510-450-7600

Kaiser Permanente Medical Center - Oakland

Bay Area Breast Surgeons Inc

94611

94609

Louis Fehrenbacher, MD

James H. Feusner

707-651-2577

510-450-7600

Epic Care - Oakland

Bay Area Tumor Institution CCOP

94612

94609

James H. Feusner, MD

James H. Feusner

510-428-3689

510-450-7600

St. Joseph Hospital Regional Cancer Center - Orange

Larry G Strieff MD Medical Corporation

Orange

Oakland

92868

94609

Chau "Cindy" N.T. Tran

James H. Feusner

714-771-8999

510-450-7600

33.78779

37.80437

-117.85311

-122.2708

Palo Alto Medical Foundation

Tom K Lee Inc

Palo Alto

Oakland

94301

94609

David S. Leibowitz

James H. Feusner

650-321-4121

510-450-7600

37.44188

37.80437

-122.14302

-122.2708

Kaiser Permanente Medical Group

Kaiser Permanente Oakland-Broadway

RECRUITING

ACTIVE_NOT_RECRUITING

Panorama City

Oakland

91402

94611

34.22473

37.80437

-118.44981

-122.2708

Pismo Beach

Oakland

93449

94611

David L. Palchak, MD

Louis Fehrenbacher

805-773-7127

626-564-3455

35.14275

37.80437

-120.64128

-122.2708

Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center

Epic Care-Oakland

Rancho Mirage

Oakland

92270

94612

Luke P. Dreisbach

James H. Feusner

760-674-3600

510-450-7600

33.73974

37.80437

-116.41279

-122.2708

Kaiser Permanente Medical Center - Redwood City

Saint Joseph Hospital

Redwood City

Orange

94063

92868

Louis Fehrenbacher, MD

Chau "Cindy" N. Tran

707-651-2577

714-734-6220

37.48522

33.78779

-122.23635

-117.85311

Kaiser Permanente Medical Center - Richmond

Desert Regional Medical Center

Richmond

Palm Springs

94801

92262

Louis Fehrenbacher, MD

Scott D. Brook

707-651-2577

760-416-4730

37.93576

33.8303

-122.34775

-116.54529

Kaiser Permanente Medical Center - Riverside

Palo Alto Medical Foundation Heath Care

Riverside

Palo Alto

92505

94301

Jonathan A. Polikoff, MD

David S. Leibowitz

619-528-5888

650-853-2906

33.95335

37.44188

-117.39616

-122.14302

Kaiser Permanente Medical Center - Roseville

Kaiser Permanente - Panorama City

Roseville

Panorama City

95661

91402

Louis Fehrenbacher, MD

Jonathan A. Polikoff

707-651-2577

626-564-3455

38.75212

34.22473

-121.28801

-118.44981

Sutter Cancer Center at Roseville Medical Center

Palchak David MD

Roseville

Pismo Beach

95661

93449

Clinical Trials Office - Sutter Cancer Center

David L. Palchak

916-454-6595

805-474-9143

38.75212

35.14275

-121.28801

-120.64128

Sutter Cancer Center

Pomona Valley Hospital Medical Center

RECRUITING

WITHDRAWN

Sacramento

Pomona

95816

91767

38.58157

34.05529

-121.4944

-117.75228

South Sacramento Kaiser-Permanente Medical Center

Kaiser Permanente-Rancho Cordova Cancer Center

RECRUITING

ACTIVE_NOT_RECRUITING

Sacramento

Rancho Cardova

95823

95670

Kaiser Permanente Medical Center - Sacramento

Eisenhower Medical Center

Sacramento

Rancho Mirage

95825

92270