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

University of Rochester

Status and phase: Withdrawn; Phase 2

Conditions: HER2-positive Breast Cancer

Treatments: Drug: Pertuzumab; Drug: Docetaxel; Drug: Trastuzumab emtansine; Drug: Carboplatin; Drug: Trastuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04419181

UBRS20013

Details and patient eligibility

About

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.

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pathologic complete response (pCR)

Experimental group

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.

Treatment:

Drug: Trastuzumab

Drug: Carboplatin

Drug: Docetaxel

Drug: Pertuzumab

Residual Disease

Experimental group

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.

Treatment:

Drug: Trastuzumab

Drug: Carboplatin

Drug: Trastuzumab emtansine

Drug: Docetaxel

Drug: Pertuzumab