Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer

NCT00429403 | Terminated Phase 3 Results DMC

• 1 other identifier: 2005-0464
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 2

Brief Summary

Primary Objective:

• To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses. Secondary Objectives:
• To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy.
• To determine the overall survival and disease-free survival times of study participants.

Conditions

Breast Cancer

Keywords

Breast Cancer; Chemotherapy; Ovarian Function; Goserelin; Zoladex; Ovary function; Fertility; Early Menopause

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Response (FSH Level + Vaginal Bleeding)

  Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both \[FSH \< 15\] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.

  Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year

Study Arms (2)

Goserelin

EXPERIMENTAL

3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.

Drug: Goserelin

No Goserelin

NO INTERVENTION

Interventions

Goserelin DRUG

3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.

Also known as: Zoladex

Goserelin

Eligibility Criteria

• Age: 15 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female patients older than 15 years and younger than 46 years.
• Primary breast cancer (Stage I, II, or III).
• Pathologically confirmed invasive breast carcinoma.
• Negative hormone-receptor status. (Negative defined as ER- and PR- staining in less than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein on ligand-binding or enzyme-linked immunoassay).
• Premenopausal, verified before chemotherapy is begun as satisfying both:
• Cyclic vaginal bleeding.
• Follicle-stimulating hormone (FSH) is less than or equal to 15 IU/L. If patients are taking oral contraceptives, FSH must be measured 1-2 weeks after discontinuation. If FSH is greater than 15 and the patient has regular menses, gynecologic consultation will be required for a decision on premenopausal status.
• Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
• Treatment with at least four (4) cycles of chemotherapy as planned.
• Zubrod performance score of 0 or 1.
• Must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
• Willingness to use barrier contraception if sexually active.

You may not qualify if:

• Pregnancy. Women must have a negative serum pregnancy test before initiation of injection.
• Hypersensitivity to any GnRH analog.
• Previous receipt of systemic chemotherapy.
• To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.
• Stage IV breast cancer.
• Prothrombin time (PT) and partial prothrombin time (PTT) with INR \> 1.5
• Platelets \< 50,000/mm\^3

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St. Luke's International Hospital

Tokyo, Japan

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Primary Ovarian Insufficiency

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; 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

Results Point of Contact

• Title: Naoto Ueno, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Naoto Ueno, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: August 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 9, 2016
• Results First Posted: July 26, 2011

Record last verified: 2011-07

Locations

US (1); JP (1)