Leuprolide + Goserelin for Breast Cancer

Overseen By Cancer AnswerLine

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must be taking: GnRHa therapy

Must not be taking: Estrogen products

Disqualifiers: Pregnancy, Breastfeeding, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two hormone therapies, leuprolide and goserelin, to determine which more effectively reduces estrogen levels in pre- or peri-menopausal women with breast cancer. Since estrogen can promote cancer cell growth, lowering it might slow the cancer's progression. Participants will receive either a lower dose of leuprolide, a higher dose of leuprolide, or goserelin to compare their effectiveness. Women who have had regular periods in the past year and plan to use hormone therapy alongside other cancer treatments might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic or transdermal estrogen products during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that leuprolide is generally safe for premenopausal women with breast cancer. It helps control hormone levels and maintains a good safety record. Patients have reported that it reduces symptoms related to ovarian function and early menopause.

Similarly, studies have found that goserelin is well-tolerated. Research indicates that both the monthly and three-month versions of goserelin are similarly safe for women with breast cancer.

Both treatments are commonly used to lower estrogen levels, which can help manage breast cancer growth. While side effects can occur, as with any treatment, past studies generally consider both leuprolide and goserelin safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about leuprolide and goserelin for breast cancer because these treatments work by targeting and suppressing hormone signals that fuel cancer growth, a different approach compared to standard chemotherapy. Leuprolide is unique because it can be administered in varying doses, potentially allowing for fine-tuning of treatment effectiveness and side effects. Goserelin, administered subcutaneously, offers a different delivery method that can be more convenient for some patients. These hormone therapies could provide more personalized and potentially less toxic options for managing breast cancer compared to conventional treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the effectiveness of leuprolide and goserelin in lowering estrogen levels in premenopausal women with breast cancer. Studies have shown that leuprolide stops the ovaries from functioning, preventing the growth of estrogen-dependent cancer cells. Data from previous studies, such as the SOFT/TEXT trials, confirm its safety and efficacy. Goserelin, which participants in this trial may also receive, is similarly effective. It has been proven to work as well as other doses and helps protect the ovaries during treatment. Both treatments lower estrogen levels, potentially slowing or stopping tumor growth. ^{1 3 4 6 7}

Who Is on the Research Team?

Norah L Henry

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for pre- or peri-menopausal women with breast cancer. It's designed to test how well two drugs, leuprolide and goserelin, can reduce estrogen production by the ovaries since estrogen can promote breast cancer cell growth.

Inclusion Criteria

Able to provide informed consent and sign approved consent form

I am a woman aged 18 or older.

I am pre- or peri-menopausal with recent periods or high estradiol levels.

Exclusion Criteria

Pregnant, breastfeeding, or planning pregnancy during study period

I have had both ovaries and fallopian tubes surgically removed.

Known allergy or hypersensitivity to specified medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive leuprolide or goserelin to suppress ovarian function, with cycles repeating every 28 days for up to 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Goserelin
• Leuprolide

Trial Overview The study compares lower dose leuprolide, higher dose leuprolide, and goserelin in their effectiveness at suppressing ovarian function to produce less estrogen. The goal is to determine which treatment is safest and most effective for these women.

How Is the Trial Designed?

Group I: Arm III (goserelin) Experimental Treatment 4 Interventions

Patients receive goserelin SC on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

Group II: Arm II (leuprolide) Experimental Treatment 4 Interventions

Patients receive higher dose leuprolide IM on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

Group III: Arm I (leuprolide) Experimental Treatment 4 Interventions

Patients receive lower dose leuprolide IM on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006218/

Goserelin 3-month depot shows non-inferiority to the ... This real-world analysis indicates that 3-month goserelin 10.8 mg is non-inferior to monthly 3.6 mg among premenopausal women with breast cancer in terms of 12 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667005425000493

Real-world effectiveness of goserelin 10.8-mg compared to ... This RWS validated the non-inferiority of goserelin 10.8-mg 3-monthly to 3.6-mg monthly in Chinese patients with HR+ breast cancer.

3. ascopubs.org ascopubs.org/doi/10.1200/OP.2024.20.10_suppl.391

Treatment patterns of goserelin 3.6 mg once monthly and ... Results: Overall, 3,620 patients were identified: 2,870 treated with goserelin 3.6 mg, 410 with goserelin 10.8 mg, and 340 who switched from ...

4. tersera.com tersera.com/TerSera-Presents-Real-World%2520Evidence-on-Treatment-Outcomes-of-Goserelin-ZOLADEX-in-Women-with-Breast-Cancer-at-the-2024-San-Antonio-Breast-Cancer-Symposium

TerSera® Presents New Real-World Evidence on ... The primary outcome was the real-world event-free survival (rwEFS) rate at 12 months to assess the non-inferiority of the goserelin 10.8 mg dose ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1413204

Goserelin for Ovarian Protection during Breast-Cancer ... Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group ( ...

6. zoladexhcp.com zoladexhcp.com/efficacy/

Efficacy and safety | ZOLADEX® (goserelin implant) On the basis of interim data from 124 women, the best objective response (CR+PR) for the ZOLADEX group was 22% vs 12% for the oophorectomy group. The median ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00655

Treatment Patterns of Goserelin 3.6 mg Once Every 4 ... Results of this real-world study of US patients with breast cancer indicate that goserelin 10.8 mg once every 12 weeks is associated with ...