Status:
WITHDRAWN
Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
Lead Sponsor:
University of Rochester
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 i...
Detailed Description
Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective esc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04419181
Start Date
August 11 2025
End Date
June 1 2027
Last Update
October 14 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642