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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00429403
Recruitment Status : Terminated (Study stopped due to low accrual.)
First Posted : January 31, 2007
Results First Posted : July 26, 2011
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Goserelin Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Response (FSH Level + Vaginal Bleeding) [ Time Frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 46 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429403


Locations
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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
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Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429403    
Other Study ID Numbers: 2005-0464
First Posted: January 31, 2007    Key Record Dates
Results First Posted: July 26, 2011
Last Update Posted: May 9, 2016
Last Verified: July 2011
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Chemotherapy
Ovarian Function
Goserelin
 Zoladex
Ovary function
Fertility
Early Menopause
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents