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NCT02614833

IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

Version 27 to 28 · Immutep S.A.S.

Patch inspector

Version 27 to 28

5 operations 3 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
eligibility_criteria_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:25+00
Raw hash
102a034d11efb77786fa8bc78ff9048a7a3a91a94b21ecc2bfb708b428d2c4d1
Payload
Source URL
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 4
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Metastatic oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy,radiation therapy or any other investigational agent within 4 weeks, endokrine therapy within 1 week prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and&#x2F;or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>
After
<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Metastatic oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4&#x2F;6 inhibitors within 5 times half-life (acc.to
SPC) prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and&#x2F;or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
replace /protocolSection/contactsLocationsModule/locations/9/status
Triage: Uncategorized
Uncategorized Operation 5
Before
NOT_YET_RECRUITING
After
RECRUITING
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2018-03
After
2018-04
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2018-03-27
After
2018-04-19
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2018-03-29
After
2018-04-20
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-04-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-04-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Metastatic oestrogen receptor positive and&#x2F;or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and&#x2F;or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2&#x2F;neu targeted agents)</li><li>Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4&#x2F;6 inhibitors within 5 times half-life (acc.to\nSPC) prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and&#x2F;or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/status",
    "value": "RECRUITING"
  }
]