Study on T-DM1 and Pertuzumab Before Surgery for Early-Stage HER2-Positive Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02326974

Provider View

This clinical trial is exploring a combination of two drugs, T-DM1 and Pertuzumab, to see if they can effectively treat early-stage breast cancer that tests positive for the HER2 protein before surgery.

Patient Parameters

Program Overview

The purpose of this study is to test if a combination of two drugs, T-DM1 and Pertuzumab, can help treat early-stage breast cancer that is HER2-positive before surgery. T-DM1 is not yet approved for use before surgery in breast cancer, but it is approved for other uses. Pertuzumab is approved for use before surgery in breast cancer.

Description

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of the drug combination to see if it works for treating early-stage HER2-positive breast cancer. The drugs being studied are T-DM1 and Pertuzumab. While T-DM1 is not approved for pre-surgery use in breast cancer, it is approved for other uses. Pertuzumab is approved for pre-surgery treatment. The study aims to find out if these drugs can help shrink tumors before surgery.

Eligibility Criteria

Inclusion Criteria

  • Must have HER2-positive Stage II or III breast cancer confirmed by lab tests, with a tumor size of at least 2 cm.
  • HER2-positive status confirmed by specific lab criteria.
  • Estrogen and progesterone receptor status must be determined.
  • Both breasts can have cancer if both are HER2-positive.
  • Can have multiple cancer sites in the breast if one meets the criteria.
  • Breast imaging must include the armpit area. If no cancer is found in the armpit, a lymph node biopsy will be done before or after treatment.
  • Men and women aged 18 and older.
  • Must be in good health with a performance status of 0 or 1.
  • Must meet specific blood test requirements for white blood cells, hemoglobin, platelets, kidney, and liver function.
  • Must test for hepatitis B and C.
  • Must have a heart function of at least 55%.
  • Premenopausal women must have a negative pregnancy test.
  • Must agree to use effective contraception during and after the study.
  • Must avoid certain medications and excessive alcohol.
  • Must be willing to sign consent and provide tissue samples for research.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Active infections or recent antibiotic treatment for infection.
  • Active liver disease or uncontrolled high blood pressure.
  • Recent heart problems or severe heart disease.
  • Severe nerve damage symptoms.
  • Other serious health conditions that could interfere with treatment.
  • Any previous treatment for the current breast cancer.

Locations

FACILITYZIPCITYSTATE
Massachusetts General Hospital02114BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts
Tennessee Oncology/Sarah Cannon Research Institute37203NashvilleTennessee
Vanderbilt-Ingram Cancer Center37232NashvilleTennessee

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