Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.

NCT07610733 | Not Yet Recruiting Phase 2

• 1 other identifier: IFOCOS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, prospective, randomized controlled, phase II study. The primary objective is to evaluate the effect of endocrine therapy modification (switching from a 3-month to a 1-month GnRHa) versus continuation of the 3-month GnRHa on E2 control at 3 months in young patients with hormone receptor-positive breast cancer and iOFS.

Conditions

Breast Cancer

Keywords

Breast Cancer; ovarian suppression

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with E2 <30 pg/mL at 3 Months

  The primary endpoint is defined as the proportion of patients with E2 \<30 pg/mL at 3 months, comparing patients who switch to GnRHa 1M versus those who continue GnRHa 3M therapy.

  3 months post randomization

Secondary Outcomes (7)

• Proportion of patients with E2 <30 pg/mL at 6 months after randomization

  6 months post randomization

• Time to adequate ovarian function suppression

  Assessed over a period of up to 12 months following randomization

• Patient Age

  At randomization

• 3-year invasive disease-free survival in patients who switch to GnRHa 1M versus those who continue GnRHa 3M therapy

  From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months

• 3-year invasive disease-free survival in patients with persistent iOFS and those with transient iOFS

  From the date of randomization until the date of locoregional recurrence, distant metastasis, second primary breast cancer, or death from any cause, up to 3 months

Study Arms (2)

Experimental: 1-month GnRH + endocrine therapy

EXPERIMENTAL

1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)

Drug: 1-month GnRH

Active Comparator: Control

ACTIVE COMPARATOR

3-month GnRH (goserelin 10.8 mg implant or leuprolide 11.25 mg depot) + endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)

Drug: 3-month GnRH

Interventions

1-month GnRH DRUG

1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)

Experimental: 1-month GnRH + endocrine therapy

3-month GnRH DRUG

3-month GnRH (goserelin 10.8 mg implant or leuprolide 11.25 mg depot) + endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)

Active Comparator: Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Step 1：iOFS detection phase
• Female, aged ≥18 and ≤45 years;
• Histologically confirmed hormone receptor-positive (HR+) (estrogen receptor \[ER\] and/or progesterone receptor \[PR\] ≥1%) and human epidermal growth factor receptor 2-negative (HER2-) early invasive breast cancer (stage I-III according to the American Joint Committee on Cancer \[AJCC\], version 8)；
• Completed curative surgery, with prior (neo)adjuvant chemotherapy and radiotherapy completed if applicable;
• Currently receiving adjuvant therapy with a 3-month GnRH agonist (GnRHa) plus aromatase inhibitor (AI) or tamoxifen (TAM), with or without CDK4/6 inhibitors (excluding abemaciclib due to its potential interference with estradiol monitoring), for ≥1 dose, and presenting with estradiol (E2) ≥30 pg/mL within 28 days prior to enrollment (measured by CLIA).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; adequate bone marrow, hepatic, renal, and cardiac function.
• Voluntarily sign a written informed consent form before the trial screening.
• Step 2：Randomized treatment phase
• iOFS confirmed using the SEMS assay (E2 ≥30 pg/mL);
• Ongoing adjuvant therapy with a 3-month GnRHa plus AI or TAM, with or without CDK4/6 inhibitors.
• No evidence of disease progression.

You may not qualify if:

• Step 1：iOFS detection phase
• Bilateral breast cancer, inflammatory breast cancer, or distant metastasis;
• Use of GnRHa for ovarian function preservation;
• History of ovarian resection or ablation; planned pregnancy or breastfeeding;
• Concomitant use of hormonal agents other than estrogen, progesterone, selective estrogen receptor modulators (SERM), or selective estrogen receptor degraders (SERD);
• Severe uncontrolled comorbidities;
• Other malignancies within the past 5 years (except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma);
• Failure to comply with follow-up or psychiatric disorders.
• Step 2：Randomized treatment phase
• a)Prior conversion from a 3-month GnRHa to a 1-month GnRHa.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Jian Zhang

CONTACT

+8664175590; syner2000@163.com

Yanchun Meng

CONTACT

+8664175590; ycmclinicaltrials@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomized into one of two groups: an intervention group that receives the 1-month GnRHa and a control group that receives the 3-month GnRHa.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into one of two groups: an intervention group that receives the 1-month GnRHa and a control group that receives the 3-month GnRHa.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 28, 2026

Record last verified: 2026-05