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Utvärdering av alternativ injektionsplats för Goserelinacetat för ovarialfunktionssuppression (OFS) hos lokala och lokalt avancerade premenopausala patienter med hormonreceptorpositiv bröstcancer

29 september 2026 uppdaterad av: Mayo Clinic

MC250301, OptiOFS: En randomiserad fas II-studie av alternativ injektionsplats för Goserelinacetat för ovarialfunktionssuppression (OFS) vid lokal och lokalt avancerad premenopausal bröstcancer

This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS) in premenopausal patients with hormone receptor positive breast cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Goserelin acetate is a drug used to treat prostate cancer, relieve the symptoms of advanced breast cancer, and treat problems with the endometrium (lining of the uterus). Goserelin acetate initially causes the pituitary gland to make more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily increasing testosterone levels in men and estrogen levels in women. With continued use, goserelin acetate lowers the amount of LH and FSH the pituitary gland releases, leading to a drop in testosterone levels in men and estrogen levels in women. Goserelin acetate may stop the growth of cancer cells that need testosterone or estrogen to grow. It is a type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. Giving goserelin acetate injections in the upper gluteal region may be as effective for OFS as giving injections in the abdomen for OFS in premenopausal patients with localized or locally advanced hormone receptor positive breast cancer.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

98

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Cancer Center Clinical Trials
  • Telefonnummer: 507-293-6386

Studieorter

  • Förenta staterna
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Rekrytering
        • Mayo Clinic in Rochester
        • Kontakt:
        • Kontakt:
          • Cancer Center Clinical Trials
          • Telefonnummer: 507-293-6386
        • Huvudutredare:
          • Karthik V. Giridhar, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years

  • REGISTRATION (STEP 1): Have histologically or cytologically confirmed, localized or locally advanced hormone positive breast cancer stage I-III (defined as ER Immunohistochemistry (IHC) > 1%] having completed curative intent therapy and clinically in remission

  • REGISTRATION (STEP 1): Currently receiving ovarian function suppression (OFS) with use of goserelin on a monthly basis in the abdomen and either aromatase inhibitor or tamoxifen for at least 6 months prior to study enrollment for treatment of hormone receptor positive breast cancer with plan to continue medical OFS for at least the next 12 months

  • REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

  • REGISTRATION (STEP 1): Provide written informed consent

  • REGISTRATION (STEP 1): Ability to complete questionnaire(s) by themselves or with assistance

  • REGISTRATION (STEP 1): Willingness to provide mandatory blood specimens for correlative research

  • REGISTRATION (STEP 1): Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

  • REGISTRATION (STEP 1): Negative serum pregnancy test =< 14 days prior to registration, and a negative urine pregnancy test =< 7 days prior to randomization

  • REGISTRATION (STEP 1): Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.

    • Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent/device. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period

  • RANDOMIZATION (STEP 2): Completion of the lead-in treatment of 6 cycles of ovarian function suppression (OFS) with use of goserelin, with estradiol E2 value of ˂ 20 pg/mL and no back to back E2 levels > 10 pg/mL after cycle 6 blood draw

Exclusion Criteria:

  • REGISTRATION (STEP 1): Any of the following prior therapies: Chemotherapy =< 6 months prior to registration. NOTE: concurrent receipt of human epidermal growth factor receptor 2 (HER2) directed antibodies or antibody-drug conjugates, endocrine therapy, or cyclin-dependent kinase (CDK) 4/6 inhibitor is permitted
  • REGISTRATION (STEP 1): Receiving any estrogen or progestin containing medications, including topical estrogens
  • REGISTRATION (STEP 1): Planning to temporarily or permanently discontinue medical OFS in the next 12 months

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm I (Goserelin acetate)

Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
Övrig: Questionnaire Administration

Ancillary studies

Läkemedel: Goserelin Acetate

Given SC

Andra namn:
  • ZDX
  • Zoladex
Experimentell: Arm II (Goserelin acetate)

Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 84 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
Övrig: Questionnaire Administration

Ancillary studies

Läkemedel: Goserelin Acetate

Given SC

Andra namn:
  • ZDX
  • Zoladex

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ovarian function suppression (OFS) maintenance
Tidsram: 6 months

Failure to maintain OFS (yes; no) is defined as estradiol ≥ 10 pg/mL on two separate occasions. Will be based on calculating the within-arm sample proportion of patients for whom upper gluteal region administration of goserelin for 6 months failed to maintain OFS after switching from monthly abdominal administration of goserelin and corresponding upper bound of the one-sided 97.5% confidence interval (CI). Provided that the upper bound of the one sided 97.5% CI excludes 10%, the primary aim for that arm will have been met.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Provider-reported adverse events (AEs)
Tidsram: Up to 1 year

Will be scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns.
Up to 1 year
Injection site preference
Tidsram: Up to 1 year

Will be measured by single-question site preference survey (abdomen, upper gluteal region, no preference or unsure).
Up to 1 year

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Patient Reported Outcomes and Quality of Life
Tidsram: Baseline, 3 months, 6 months, 9 months, 12 months

Assessed by a study-specific questionnaire related to injection pain and post-injection symptoms such as bruising, swelling, or skin irritation. The questionnaire consists of 7 questions, one yes/no question; 5 questions answered on an 11-point scale from 0 (none) to 10 (most you can imagine); and one overall quality of life question answered on a scale of 0 (as bas as it can be) to 10 (as good as it can be). Higher scores for symptom questions indicate more sever symptoms. Any change from baseline will be summarized descriptively.
Baseline, 3 months, 6 months, 9 months, 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Mayo Clinic

Utredare

  • Huvudutredare: Karthik V. Giridhar, MD, Mayo Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 maj 2026

Primärt slutförande (Beräknad)

21 december 2028

Avslutad studie (Beräknad)

21 juni 2029

Studieregistreringsdatum

Först inskickad

4 mars 2026

Först inskickad som uppfyllde QC-kriterierna

4 mars 2026

Första postat (Faktisk)

10 mars 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MC250301
  • MC250301 (Annan identifierare: Mayo Clinic)
  • NCI-2026-00968 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • 25-006670 (Annan identifierare: Mayo Clinic Institutional Review Board)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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