NCT03716180

DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC

DAPHNe: De-escalation to Adjuvant Antibodies Post-pCR to Neoadjuvant THP (Paclitaxel/Trastuzumab/Pertuzumab)-a Pilot Study in HER2-positive Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants treated with a combination of drugs as a treatment for breast cancer. The names study drugs involved in this study are: * Paclitaxel (also called Taxol) * Trastuzumab (also called Herceptin) * Pertuzumab (also called Perjeta)

Detailed description

This research study is a Pilot Study, which means investigators are looking at the feasibility of a new approach for deciding the optimal medical treatment for this type of breast cancer. The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab, and pertuzumab as part of a pre-operative treatment option for this disease. The purpose of this study is to evaluate whether participants and their doctors are willing to accept a treatment recommendation for post-operative chemotherapy, on the basis of the participant's response to pre-operative treatment with paclitaxel, trastuzumab, and pertuzumab. In addition, the investigators are evaluating how the body's immune system works with paclitaxel, trastuzumab, and pertuzumab to kill cancer cells. For this reason, the investigators will collect samples of the participant's breast tumor and samples of the participant's blood over time to understand the reaction of the immune system to the participant's tumor.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug
DRUG	Trastuzumab	Trastuzumab works by targeting the HER2/neu receptor on cancer cells
DRUG	Pertuzumab	Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death

Timeline

• Start date: 2018-11-05
• Primary completion: 2020-10-08
• Completion: 2030-09-01
• First posted: 2018-10-23
• Last updated: 2025-09-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study