Study on Darolutamide with Standard Therapy Before Surgery for Stage II-IIIA Androgen Receptor Positive Triple-Negative Breast Cancer

Sponsor: Vandana Abramson

Sponsor score: 0

ClinicalTrials ID:NCT07016399

Provider View

This clinical trial is exploring whether adding the drug darolutamide to the usual treatment before surgery can help shrink tumors in patients with stage II-IIIA androgen receptor positive triple-negative breast cancer. The standard treatment usually includes chemotherapy and immunotherapy.

Patient Parameters

Program Overview

This study is testing if adding darolutamide to the standard treatment before surgery can help control stage II-IIIA androgen receptor positive triple-negative breast cancer. Standard treatment typically involves chemotherapy drugs like carboplatin, paclitaxel, doxorubicin, and cyclophosphamide, which work to stop cancer cells from growing and spreading. Immunotherapy with pembrolizumab helps the immune system attack cancer cells. Darolutamide blocks male hormones that can help cancer grow. The goal is to see if this combination can make tumors smaller and reduce the amount of normal tissue that needs to be removed during surgery.

Description

The main goal of this study is to compare the effects of darolutamide with standard treatment on a specific marker in cancer cells called Ki-67. Researchers will also look at how well the cancer responds to treatment and how long patients stay free of cancer events. They will monitor changes in cancer DNA in the blood and how these changes relate to treatment response. The study will also explore how darolutamide affects cancer cell behavior and the surrounding tumor environment.

Participants are divided into two groups:

  • Group A: Receives standard treatment with pembrolizumab, paclitaxel, and carboplatin for up to 4 cycles, followed by pembrolizumab, cyclophosphamide, and doxorubicin or epirubicin for another 4 cycles. Surgery, imaging, blood tests, and biopsies are part of the study.

  • Group B: Starts with darolutamide for 14 days, then receives darolutamide with pembrolizumab, paclitaxel, and carboplatin for up to 4 cycles, followed by pembrolizumab, cyclophosphamide, and doxorubicin or epirubicin for another 4 cycles. Surgery, imaging, blood tests, and biopsies are part of the study.

After treatment, patients are followed up at 30-37 days, 6 months, 12 months, and then yearly for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent and ability to understand the study.
  • Age 18 or older.
  • Good overall health (ECOG status 0 or 1).
  • Newly diagnosed breast cancer with specific characteristics:
    • Less than 10% estrogen and progesterone receptor positive.
    • HER2 negative.
    • At least 80% androgen receptor positive.
  • Tumor size 1 cm or larger, or stage II-IIIA, eligible for pre-surgery treatment.
  • Adequate blood cell counts and organ function.
  • Not breastfeeding and agree not to breastfeed during and after treatment.
  • Women of childbearing potential must have a negative pregnancy test and use contraception.
  • Men must agree to use contraception and not donate sperm during and after treatment.

Exclusion Criteria

  • Breast cancer that cannot be surgically removed or has spread.
  • Other cancers within the last 5 years, except certain low-risk types.
  • Pregnant or breastfeeding women.
  • Moderate liver impairment.
  • Participation in another study with investigational drugs within 4 weeks.
  • Previous organ transplant recipients.
  • Severe allergies to study drugs.
  • Significant heart disease or recent stroke.
  • Uncontrolled illness or psychiatric conditions.
  • Conditions that prevent the use of checkpoint inhibitors.

Locations

FACILITYZIPCITYSTATE
Vanderbilt University/Ingram Cancer Center37232NashvilleTennessee

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