Study on How Tumor Shrinkage Before Surgery Relates to Remaining Cancer in Early Breast Cancer Patients

Sponsor: Baylor Breast Care Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05020860

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This study aims to find out if the amount a breast tumor shrinks during chemotherapy before surgery can predict how much cancer remains after surgery. It focuses on patients with certain types of breast cancer receiving standard chemotherapy treatment.

Patient Parameters

Program Overview

The study is investigating whether the reduction in tumor size, as seen through imaging or physical exams during chemotherapy before surgery, can predict the amount of cancer left after surgery in breast cancer patients. This approach, known as neoadjuvant therapy, is already used to improve surgical outcomes and assess how well the cancer responds to treatment. Patients who have no remaining cancer after this treatment tend to have better outcomes, especially those with HER2+, triple-negative, or aggressive ER+ breast cancer. The study will explore early predictors of complete cancer removal, such as tissue, blood, and imaging markers, to potentially tailor future treatments and avoid ineffective therapies. Participants with triple-negative breast cancer will undergo additional imaging and biopsies to study these predictors.

Description

Neoadjuvant therapy, which involves giving chemotherapy before surgery, was initially used to improve surgical outcomes in breast cancer. It allows doctors to see how well the cancer responds to treatment before surgery. Patients who have no cancer left after this treatment, known as a pathologic complete response (pCR), generally have better outcomes, especially those with HER2+, triple-negative, or aggressive ER+ breast cancer. Currently, the only way to know if a patient achieves pCR is to complete the full course of therapy and then perform surgery.

Researchers are interested in finding early signs that predict pCR, which could help tailor treatments to each patient and avoid ineffective therapies. These signs might include changes in tissue, blood, or imaging results. In some trials, patients have shown significant tumor shrinkage early in treatment, and many of these patients achieve pCR at surgery. If this observation is confirmed, it could lead to a simple way to predict pCR using exams and imaging.

The study will also look at imaging and molecular changes to predict pCR. A group of researchers will study image analysis and genetic changes early in treatment to predict response, focusing on participants with triple-negative breast cancer. These participants will have additional biopsies and MRIs before and after the first treatment cycle.

The researchers believe that if a tumor does not shrink by at least 30% by Day 21 of treatment, it is likely that pCR will not be achieved at surgery in patients with triple-negative, HER2+, or high-risk ER+ breast cancer. All treatments in this study are standard and not experimental.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give consent. Both men and women can participate.
  • Must have confirmed invasive breast cancer, which can be triple-negative, HER2-positive, or high-risk estrogen receptor positive.
  • Tumors must be at least 2 cm in size.
  • If there are cancers in both breasts, one must be chosen for study assessments, and the same treatment must be suitable for both.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have normal heart function as shown by specific tests.
  • Must have adequate organ function based on blood tests.
  • Women of childbearing potential must agree to use effective, non-hormonal birth control during treatment.
  • Participation in another clinical trial is allowed with approval.

Exclusion Criteria

  • Cannot have Stage IV breast cancer.
  • Cannot have inflammatory breast cancer.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had certain breast surgeries before joining the study.
  • Cannot have had previous treatment with specific cancer drugs.
  • Cannot have had treatment for the current breast cancer diagnosis.
  • Cannot have a history of heart disease that would prevent using the study drugs.
  • Cannot have current infections like HIV, hepatitis B, or hepatitis C.
  • Cannot have had other cancers within the last 5 years, except for certain skin cancers.
  • Cannot have other serious health conditions that would prevent treatment or follow-up.
  • Cannot have psychiatric or social issues that would prevent meeting study requirements.

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