Clinical trial · Interventional
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer
NCT07217990CI-TRIAL-00115682NoCUT-BCnot yet recruitingPhase 1 / Phase 2ClinicalTrials.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 study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen collection | Procedure | — | UNRESOLVED |
| Breast Cancer Surgery | Procedure | — | UNRESOLVED |
| MRI | Procedure | — | UNRESOLVED |
| Neoadjuvant Chemotherapy | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (eeCR, non-surgical)
- description
- Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up.
- interventionNames
- Drug: Neoadjuvant Chemotherapy
- Radiation: Radiation Therapy
- Procedure: MRI
- Procedure: Biopsy
- Procedure: Biospecimen collection
- type
- EXPERIMENTAL
- label
- Arm B (non-eeCR, surgical)
- description
- Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype 5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT) Exclusion Criteria: 1. Pregnancy or lactation 2. Inmate or prisoner 3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment 4. Patients with skin involvement and/or distant metastases
References
Publications (0)
Data not yet available
No reference posted for this study.