Breast CancerPhase 3NCT00429403
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
A Phase 3 study testing Goserelin in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 46 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Goserelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 46 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Goserelin
- Keywords
- Breast Cancer, Chemotherapy, Ovarian Function, Goserelin, Zoladex, Ovary function, Fertility, Early Menopause
- Medical subject headings
- Breast Neoplasms, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
Also called Zoladex
3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
| Study group | Role | What they receive |
|---|---|---|
| Goserelin | Experimental | 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. Receives: Drug: Goserelin |
| No Goserelin | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Study stopped due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naoto Ueno, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429403
- Sponsor's protocol ID
- 2005-0464
- Status last verified
- Jul 2011
- First submitted
- 29 Jan 2007
- Last updated
- 9 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
- ClinicalTrials.gov ID
- NCT00429403
- Acronym / sponsor ID
- 2005-0464
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Chemotherapy, Ovarian Function, Goserelin, Zoladex, Ovary function, Fertility, Early Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Posted 26 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goserelin | Experimental | Drug: Goserelin3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. |
| No Goserelin | No intervention | – |
Who may qualify
- Ages
- 15 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoserelinAlso: Zoladex3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose. | Drug | Goserelin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoto Ueno, MD, PhD principal investigator
M.D. Anderson Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goserelin in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Response (FSH Level + Vaginal Bleeding) (time frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.