Back to trial

NCT01471106

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Version 10 to 11 · M.D. Anderson Cancer Center

Patch inspector

Version 10 to 11

4 operations 2 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
primary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:13+00
Raw hash
d2d7250072c1b2e5a76ecc6e781fff25d5cb532c03ec5980b30b12dff1199a0c
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 4
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Primary endpoint is the change in Ki-67 before and after 3 months of dasatinib treatment in breast tissue of high-risk women.
Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
The purpose of this study is to determine the minimum biological effective dose, which is defined as the lowest dose where the change of Ki-67 is significantly different from that in the control group.
After
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples.
Samples evaluated by immunohistochemistry (IHC).
Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage.
Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
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
2015-04
After
2015-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-04-09
After
2015-10-05
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2015-04-10
After
2015-10-07
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2015-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-10-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-10-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples.\nSamples evaluated by immunohistochemistry (IHC).\nBaseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage.\nKi-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control."
  }
]