Hormone Replacement Therapy for BRCA Mutation Carriers

(BRCA HRT Pilot Trial)

Overseen By Amelia Scott

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cancer, Postmenopausal, Over 50, others

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop an educational tool about hormone replacement therapy (HRT) for women with BRCA gene mutations. The research helps these women understand the risks and benefits of HRT before undergoing preventive surgery to remove their ovaries and fallopian tubes. Participants will receive either standard information or a new video-based educational aid about HRT. Women who carry BRCA1 or BRCA2 mutations, are premenopausal, and plan this specific surgery at Duke might be a good fit. As an unphased trial, this study allows participants to contribute to creating a valuable educational resource that could benefit many women facing similar decisions.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hormone replacement therapy is safe for BRCA mutation carriers?

Studies have shown that hormone replacement therapy (HRT) is generally safe for women with BRCA mutations. Specifically, research indicates that using HRT after ovary removal does not increase breast cancer risk for women with the BRCA1 mutation. This suggests many women can use HRT without additional cancer concerns. However, one study found that HRT might increase breast cancer risk in BRCA carriers under 45.

Overall, HRT effectively manages menopause symptoms, but it is not widely used among women with BRCA mutations. While current evidence suggests HRT can be safe, individuals should discuss their personal risks and benefits with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Hormone Replacement Therapy (HRT) for BRCA mutation carriers because it offers a tailored approach to managing hormonal deficiencies after risk-reducing surgeries. Unlike standard care, which typically involves verbal counseling and written information, this approach incorporates a video-based educational aid. This innovative method aims to better inform patients about the risks and benefits of HRT, potentially improving understanding and decision-making. By enhancing patient education, researchers hope to empower individuals with BRCA mutations to make more informed choices about their health post-surgery.

What evidence suggests that hormone replacement therapy could be effective for BRCA mutation carriers?

Research has shown that hormone replacement therapy (HRT) is generally safe for women with BRCA gene changes, particularly when used short-term. Studies have found that short-term HRT does not increase the risk of breast cancer in women with a BRCA1 gene change. Although there is less information on BRCA2, the results remain promising. For women under 45, HRT appears to be a safe option. In this trial, participants in the experimental arm will receive standard verbal counseling and written education, along with a video-based educational aid detailing the risks and benefits of HRT. Overall, using HRT for a short time after surgery to reduce cancer risk seems to be a safe choice for women with BRCA gene changes. ^{1 2 6 7 8}

Who Is on the Research Team?

Laura Havrilesky

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for premenopausal women with a BRCA1 or BRCA2 gene mutation who are scheduled to undergo a risk-reducing salpingo-oophorectomy (RRSO) by a Duke Gynecologic Oncologist. It aims to help them understand hormone replacement therapy.

Inclusion Criteria

I have a BRCA1 or BRCA2 gene mutation.

I am scheduled for surgery to remove my ovaries and fallopian tubes at Duke.

I am premenopausal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants are randomized to receive either standard education or standard education plus video education about HRT

Baseline to pre-randomization

Intervention

Participants review educational materials and their decisional conflict is reassessed preoperatively

Immediately after the intervention

Post-operative Follow-up

Participants' decisional conflict and satisfaction with counseling and decision are assessed

2-6 weeks post op

Long-term Follow-up

Participants' satisfaction with decision and HRT uptake are assessed

3-6 months post op

What Are the Treatments Tested in This Trial?

Interventions

• Hormone Replacement Therapy

Trial Overview The study compares two approaches: the Experimental Arm, which involves an educational aid about hormone replacement therapy, and the Standard of Care (SOC) Arm, without this additional information.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

The experimental arm will receive standard verbal counseling and written education plus the video-based educational aid describing the risks and benefits of HRT.

Group II: Standard of Care Placebo Group 1 Intervention

The control arm will receive standard counseling regarding post operative HRT by their gynecologic oncologist during their visit, as well as standardized written education in their after-visit summary.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8164576/

Hormone replacement therapy in BRCA mutation carriers ... Although data are limited, HRT does not seem to have a relevant effect on cancer risk in BRCA mutation carriers.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804921000897

Breast cancer risk and hormone replacement therapy ... Hormonal replacement treatment (HRT) appears safe in BRCA carriers under 45 years old. HRT was associated with a tripled breast cancer risk for BRCA carriers ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT183460

Hormone replacement therapy (HRT) among <em>BRCA ... Results: According to the survey findings, 73% of BRCA mutation carriers were postmenopausal (59% previvors, 88% survivors) and, among these, 81% had become ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36637775/

Hormone replacement therapy in BRCA mutation carriers There is strong evidence that short-term HRT use does not increase the risk of breast cancer among women with a BRCA1 mutation. Few data are available on BRCA2 ...

5. e-crt.org e-crt.org/DOIx.php?id=10.4143/crt.2023.653

Short-term Impact of Hormone Replacement Therapy on ... In conclusion, our findings showed that the use of short-term post-RRSO HRT does not increase the risk of breast cancer in populations with BRCA mutations.

6. ejgo.org ejgo.org/pdf/10.3802/jgo.2024.35.e70

Hormone replacement therapy in gynecological cancer ... Hormone replacement therapy is effective but remains underused in gynecological cancer and BRCA-mutated patients.

7. mdpi.com mdpi.com/2072-6694/15/3/711

Long-Term Non-Cancer Risks in People with BRCA ... Results were in agreement with Rebbeck et al., showing that HRT use following RRBSO was not associated with an increase in risk of breast cancer in BRCA1 and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804921000897

Breast cancer risk and hormone replacement therapy ... Hormonal replacement treatment (HRT) appears safe in BRCA carriers under 45 years old. HRT was associated with a tripled breast cancer risk for BRCA carriers ...