Clinical trial · Observational
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
NCT03981705CI-TRIAL-00084075completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ERany/PRany/HER2+ Breast Cancer | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| TN ER-/PR-/HER2- Breast Cancer | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Trimodality Breast Imaging | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete Pathologic Response (pCR)
- timeFrame
- 6 Months Post Surgery
- description
- The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsyproven triple negative or HER2+ breast cancer.
Secondary outcomes (1)
- measure
- Complications and Side Effects of the Needle Biopsy Procedure after NAC
- timeFrame
- 6 Months Post Surgery
- description
- Incidence of Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned * A biopsy clip placed at the time of diagnostic biopsy * 18 years of age or older * Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation * Able to provide written consent prior to any research related activities Exclusion Criteria: * Stage IV breast cancer * T4 breast cancer * Previous ipsilateral breast cancer * Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
References
Publications (0)
Data not yet available
No reference posted for this study.