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Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT07158021

Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial

A Phase 2 study testing Biospecimen Collection, Electronic Health Record Review and Goserelin in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Electronic Health Record Review and Goserelin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
22 Jan 2026to 1 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female subject aged ≥ 18 years
  • Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.
  • Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.
  • Not planning bilateral salpingo-oophorectomy during the 6-month study duration
  • Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4/6 (CDK4/6) inhibitor, and/or phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Who cannot join

  • Prior bilateral salpingo-oophorectomy
  • Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)
  • Concomitant use of systemic or transdermal estrogen products
  • Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
  • Unable to take oral medications
  • Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
  • Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Norah L. Henry

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)

This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.

Read the detailed description

13MAY2026- New Amendment approved which made the following changes:

  • Study title updated reflect updated trial design
  • Arms updated to reflect study drug dosing assignments
  • Eligibility Criteria
Being tested
Biospecimen Collection, Electronic Health Record Review, Goserelin, Leuprolide, Questionnaire Administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Electronic Health Record ReviewOther

    Ancillary studies

  • GoserelinDrug

    Also called ICI-118630

    Given SC

  • LeuprolideDrug

    Also called Leuprorelin

    Given IM

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07158021
Study groupRoleWhat they receive
Arm I (leuprolide)ExperimentalLeuprolide 3.75 mg q4weeks. 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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Leuprolide; Other: Questionnaire Administration
Arm II (leuprolide)ExperimentalLeuprolide 7.5 mg q4weeks. 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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Leuprolide; Other: Questionnaire Administration
Arm III (goserelin)ExperimentalGoserelin 3.6 mg q4 weeks. 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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Goserelin; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml

    Analyses will primarily be descriptive reporting the overall and by treatment group proportions of women with ultrasensitive estradiol concentration and the corresponding exact binomial 95% confidence intervals over the first 24 weeks of gonadotropin releasing hormone agonist (GnRHa) therapy.

    Measured: During the first 24 weeks of therapy

Secondary outcomes (8)

  1. Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml

    Will be described with corresponding 95% confidence intervals overall and by treatment group.

    Measured: At 4 weeks after initial GnRHa treatment administration

  2. Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml

    Will be described with corresponding 95% confidence intervals overall and by treatment group.

    Measured: Any time after 4 weeks of initial GnRHa treatment administration, assessed cycle 3 day 1-cycle 7 day 1 (cycle length = 28 days)

  3. Change in Functional Assessment of Cancer Therapy-(FACT)-Endocrine Subscale (ES) Trial Outcome Index

    Will use linear mixed-effects models with fixed effects for study group, time, and their interaction. For each outcome, a random intercept for each participant will be included to account for within-subject correlation. This approach allows for estimation of longitudinal trends in FACT-ES scores and assessment of whether changes over time differ between treatment arms. Missing data will be handled using maximum likelihood estimation under the assumption of missing at random (MAR).

    Measured: Up to 24 weeks

  4. Change in FACT-ES Endocrine Symptom Subscale

    Will use linear mixed-effects models with fixed effects for study group, time, and their interaction. For each outcome, a random intercept for each participant will be included to account for within-subject correlation. This approach allows for estimation of longitudinal trends in FACT-ES scores and assessment of whether changes over time differ between treatment arms. Missing data will be handled using maximum likelihood estimation under the assumption of MAR.

    Measured: Up to 24 weeks

  5. Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire

    Will be described by study arm and with corresponding exact binomial 95% confidence intervals.

    Measured: At the day following initial GnRHa injection

  6. Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire

    Will be described by study arm and with corresponding exact binomial 95% confidence intervals.

    Measured: Before administration of the second GnRHa injection

  7. Receipt of GnRHa therapy within ± 1 day of planned dosing

    Planned dosing should be given every 28 days. The proportion of patients who receive GnRHa therapy within ± 1 day of planned dosing will be reported overall and by study arm with corresponding exact binomial 95% confidence intervals.

    Measured: Up to 24 weeks

  8. Incidence of adverse events (AEs)

    AEs will be graded and described using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be reported using descriptive statistics for each GnRHa study arm.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start22 Jan 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158021
Sponsor's protocol ID
UMCC 2025.016
Other IDs
NCI-2025-03933, HUM00270281
Status last verified
Feb 2026
First submitted
27 Aug 2025
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: participant demographics, estradiol concentrations, and patient-reported outcomes data will be available to researchers upon reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Electronic Health Record Review and Goserelin in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml (time frame: During the first 24 weeks of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07158021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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