Study on Reducing Chemotherapy for Breast Cancer Patients After Pre-surgery Treatment

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04266249

Provider View

This clinical trial is exploring whether patients with HER2-positive stage II-IIIa breast cancer can safely receive less chemotherapy after surgery if their cancer is completely gone following pre-surgery treatment with specific drugs.

Patient Parameters

Program Overview

The trial is investigating if using the drugs paclitaxel, trastuzumab, and pertuzumab before surgery can help patients with HER2-positive stage II-IIIa breast cancer avoid further chemotherapy after surgery. These drugs work by stopping cancer cells from growing and spreading. Trastuzumab and pertuzumab are targeted therapies that attach to HER2 receptors on cancer cells, blocking signals that make the cells grow and marking them for destruction by the immune system. The study aims to see if this approach can maintain patient outcomes while reducing the need for additional chemotherapy.

Description

The main goal of this study is to see if patients with HER2-positive breast cancer who have no remaining cancer after pre-surgery treatment can have a 3-year recurrence-free survival rate of over 92%. The study also looks at other survival outcomes and the safety of reducing chemotherapy after surgery.

Before surgery, patients receive a combination of chemotherapy and targeted therapy drugs. After surgery, patients are divided into two groups based on whether they have any remaining cancer. Those with no remaining cancer continue with targeted therapy, while those with remaining cancer receive additional treatment.

The study will follow patients for several years to monitor their health and the effectiveness of the treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have HER2-positive breast cancer confirmed by specific tests.
  • Must have stage II or IIIa breast cancer at diagnosis.
  • Must be willing to receive standard post-surgery therapy if no cancer remains after surgery.
  • Can have a history of other cancers if disease-free for at least 5 years.
  • Must have normal heart function and no severe nerve damage.
  • Must have recent breast and axillary imaging.
  • Must agree to use effective contraception during and after the study.
  • Must be willing to sign informed consent.
  • Must meet specific blood and liver function test criteria.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.

Exclusion Criteria

  • Must not have impaired decision-making capacity.
  • Must not have a history of invasive breast cancer, except for specific cases.
  • Must not have stage IV breast cancer.
  • Must not have certain severe medical conditions or be pregnant or breastfeeding.
  • Must not have received any prior treatment for the current breast cancer.
  • Must not have severe nerve damage or uncontrolled medical conditions.

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