Clinical trial · Interventional
Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years.
Summary
Brief summary (as posted)
The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Trastuzumab emtansine | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pathologic complete response (pCR)
- description
- Participants will receive four cycles of TCHP \[docetaxel (Taxotere®), carboplatin, trastuzumab (Herceptin®), pertuzumab\], followed by surgery. Participants who achieve pathologic complete response will receive infusions of trastuzumab every 3 weeks for a total of 12 cycles/infusions.
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Trastuzumab
- Drug: Pertuzumab
- type
- EXPERIMENTAL
- label
- Residual Disease
- description
- Participants will receive four cycles of TCHP \[docetaxel (Taxotere®, carboplatin, trastuzumab (Herceptin®), pertuzumab\], followed by surgery. Participants who have residual disease may be offered two more cycles of TCHP in the adjuvant settings (optional) per treating oncologist's discretion and then will receive infusion of Trastuzumab Emtansine (TDM1) plus pertuzumab every three weeks for a total of 12 cycles/infusions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥18 years of age * Biopsy proven HER2+ early breast cancer * ECOG performance status 0-1 * Should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease. * Adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion. * Women of childbearing potential who are sexually active must agree to use highly effective methods of contraception during treatment and for three weeks after the last dose of chemotherapy or anti-HER2 therapy. The women currently using hormonal contraceptives must agree to change to an alternative highly effective method of contraception * Willingness and ability to comply with study and follow-up procedures and give written informed consent. Exclusion Criteria: * Any evidence of stage IV breast cancer * Participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved * Any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer. * Women who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available