Study on the Effect of Denosumab in Preventing Breast Cancer in Women with a BRCA1 Gene Mutation

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04711109

Provider View

This clinical trial is testing whether the drug denosumab can help prevent breast cancer in women who have a specific inherited BRCA1 gene mutation, which increases their risk of developing breast cancer.

Patient Parameters

Program Overview

This study is comparing the effects of denosumab, a medication used to treat bone loss, with a placebo to see if it can prevent breast cancer in women with a BRCA1 gene mutation. This mutation is inherited and is linked to a higher risk of breast and other cancers. Denosumab is already used to prevent bone fractures and reduce bone growths in cancer patients, and researchers are investigating if it can also lower the risk of breast cancer in women with this genetic mutation.

Description

The main goal of this study is to see if denosumab can reduce the risk of developing any type of breast cancer, including invasive breast cancer and ductal carcinoma in situ (DCIS), in women with a BRCA1 gene mutation compared to a placebo.

Other goals include:

  • Checking if denosumab can lower the risk of invasive breast cancer and triple-negative breast cancer (TNBC) in these women.
  • Seeing if it can reduce the risk of ovarian, fallopian, and peritoneal cancers in women who haven't had surgery to remove their ovaries and fallopian tubes.
  • Evaluating if it can lower the risk of other cancers linked to the BRCA1 mutation.
  • Determining if it can reduce the risk of bone fractures in women before and after menopause.
  • Comparing the number of breast biopsies and benign breast conditions in women taking denosumab versus a placebo.

Participants are randomly assigned to one of two groups:

  • Group A: Receives denosumab injections every six months for up to five years, unless breast cancer develops or side effects are unacceptable.
  • Group B: Receives placebo injections every six months for up to five years, unless breast cancer develops.

After finishing the treatment, participants will have follow-up visits every year for five years.

Eligibility Criteria

Inclusion Criteria

  • Women with a confirmed harmful BRCA1 gene mutation.
  • Aged between 25 and 55 years.
  • No signs of breast cancer from recent MRI or mammogram and clinical breast exam.
  • No signs of ovarian cancer.
  • Negative pregnancy test for women who can become pregnant.
  • No planned preventive breast surgery.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Willing to provide written consent before any study procedures.

Exclusion Criteria

  • Have had both breasts removed.
  • History of ovarian or breast cancer.
  • History of other invasive cancers, except for certain skin cancers or early-stage cervical or thyroid cancer.
  • Pregnant or breastfeeding within the last two months.
  • Not willing to use effective birth control during and for at least five months after treatment.
  • Low calcium levels or history of low calcium.
  • Recent or long-term use of certain hormone therapies.
  • Previous use of denosumab.
  • History of jaw bone problems or need for oral surgery soon.
  • Current treatment with certain bone or cancer medications.
  • Major medical or psychiatric conditions that could interfere with the study.
  • Active infections with hepatitis B, hepatitis C, or HIV.
  • Use of other investigational drugs (current or past use of aspirin or NSAIDs is allowed).

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