RecruitingNot ApplicableNCT04281641

Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer

Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer

Sponsor

Fudan University

Enrollment

94 participants

Start Date

Apr 21, 2020

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at blood and tumor markers (biological signals in the body) to see which ones best predict how well a targeted pre-surgery treatment (combining two drugs that target the HER2 protein) works for HER2-positive breast cancer. The goal is to help doctors personalize treatment decisions. **You may be eligible if...** - You are 18–70 years old (male or female) - You have been newly diagnosed with HER2-positive breast cancer - Your tumor is larger than 2 cm - You have not had any previous cancer treatment - Your heart function is good (ejection fraction at or above 55%) **You may NOT be eligible if...** - You have received any prior treatment for an invasive cancer - Your heart function is too low - You are unable to participate in surgery or provide tissue samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTCHP

Drug: Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV Other Name: Herceptin Drug: Pertuzumab 840 mg as a loading dose, then 420 mg every 3 weeks, IV Other Name: Perjeta Drug: carboplatin at target area under the plasma concentration-time curve (AUC) 6 Drug: docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w). All study drugs were administered intravenously. Procedure: 18-FDG-PET and 68 Ga-Affibody HER-2 Imaging PET will be performed at baseline, on day 15 and before surgery Genomic alterations (mutations/somatic rearrangements) are detected at baseline, on day 15 and before surgery.