Breast Cancer Clinical Trial

Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer

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 in early-stage HER2 positive breast cancer.

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Full 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 escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.

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Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04419181

Recruitment Status:

Suspended

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester Medical Center
Rochester New York, 14642, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT04419181

Recruitment Status:

Suspended

Sponsor:


University of Rochester

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