Primary outcomeNumber· Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Number of Patients With Response (FSH Level + Vaginal Bleeding)
| Group | Value (participants) |
|---|---|
| Goserelin | 1 |
| No Goserelin | not posted |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataGoserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
NCTNCT00429403 (opens ClinicalTrials.gov in a new tab)Other id2005-0464
This trial was stopped early.
Reason given at the registry: Study stopped due to low accrual.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 1 participants (actual)
- Sponsor
- M.D. Anderson Cancer Center · Other
- Design
- Randomized · Open label (no masking)
- Countries
2 countries
United States, Japan
- Start
- Aug 2006
- Primary completion
- Jul 2010
- Completion
- Jul 2010
- First posted
- 31 Jan 2007 (estimated)
- Last update posted
- 9 May 2016 (estimated)
- Conditions
- Breast Cancer
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200620072008200920102011
- Ph 3Terminated
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
NCT00429403Aug 2006 to Jul 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- GoserelinDrug
Arms2
Experimental
Goserelin
3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
No intervention
No Goserelin
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Patients With Response (FSH Level + Vaginal Bleeding)
Time frame · Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Goserelin3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. | – | 0 / 1 | 0 / 1 |
| No Goserelin | – | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 15 Years up to 46 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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