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

This study has been terminated.
(Study stopped due to low accrual.)
Sponsor:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429403
First received: January 29, 2007
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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.

Condition Intervention Phase
Breast Cancer
Drug: Goserelin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients With Response (FSH Level + Vaginal Bleeding) [ Time Frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: August 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Goserelin
3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
Drug: Goserelin
3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
Other Name: Zoladex
No Intervention: No Goserelin

Detailed Description:

Goserelin is designed to block hormones that can regulate your menstruation by affecting the pituitary gland (part of brain).

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. You will either be assigned to receive goserelin or no treatment. There is an equal chance of being assigned to either group.

If you are assigned to receive goserelin, the first dose will be given as an injection under the skin, 1 week before you start chemotherapy. You will then receive chemotherapy as part of your standard of care. Following the first dose of goserelin, you will be given a goserelin injection into the skin, once a month until 3 weeks after the last chemotherapy dose.

You will be taken off study if intolerable side effects occur during this study. After you are finished with chemotherapy, you will have a series of follow-up visits. During the period of follow-up, you will have a medical history, physical exam, and blood tests (2-3 teaspoons) to evaluate your ovarian function, every 3 months for 1 year and then at 24 months. You will be asked to fill out questionnaires about your menstrual history at these visits. The questionnaires should take about 15 minutes to complete. You will be also asked to fill out questionnaires about your quality of life at 12 and 24 months. The questionnaires should take about 30 minutes to complete.

This is an investigational study. Goserelin is commercially available and has been approved by the FDA for use in breast cancer patients. Its use in this study is investigational. About 148 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M.D. Anderson.

  Eligibility

Ages Eligible for Study:   15 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients older than 15 years and younger than 46 years.
  2. Primary breast cancer (Stage I, II, or III).
  3. Pathologically confirmed invasive breast carcinoma.
  4. 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).
  5. 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.
  6. Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
  7. Treatment with at least four (4) cycles of chemotherapy as planned.
  8. Zubrod performance score of 0 or 1.
  9. Must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
  10. Willingness to use barrier contraception if sexually active.

Exclusion Criteria:

  1. Pregnancy. Women must have a negative serum pregnancy test before initiation of injection.
  2. Hypersensitivity to any GnRH analog.
  3. Previous receipt of systemic chemotherapy.
  4. To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.
  5. Stage IV breast cancer.
  6. Prothrombin time (PT) and partial prothrombin time (PTT) with INR > 1.5
  7. Platelets < 50,000/mm^3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429403

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Japan
St. Luke's International Hospital
Tokyo, Japan
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Naoto Ueno, MD, PhD/Associate Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429403     History of Changes
Other Study ID Numbers: 2005-0464
Study First Received: January 29, 2007
Results First Received: June 27, 2011
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Chemotherapy
Ovarian Function
Goserelin
Zoladex
Ovary function
Fertility
Early Menopause

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014