Breast CancerPhase 3NCT01530607
Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
A Phase 3 study testing Standard cyclophosphamide and Goserelin (Zoladex) in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center.
Trial summary
This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard cyclophosphamide and Goserelin (Zoladex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, or IIIA invasive breast cancer. Patients who have completed surgery must have pathologic Stage I, II, or IIIa disease. Patients to be treated in the preoperative setting may be staged clinically but must have operable disease. For the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and estradiol levels in the premenopausal range.
- Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative.
- Patients must be of age 18 or greater and under age 50.
- The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
- For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting
- Patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.
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- Patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition. Patients currently enrolled on S0221 are eligible for this study.
- Patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: Women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. In addition, for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization.
- Women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation of FSH and estradiol levels in the premenopausal range.
- No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been diseasefree for five years after treatment with curative intent.
- Patients must have a performance status of 0 - 2 by Zubrod criteria (see Section 10.4).
- Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential must agree to use an effective barrier contraceptive method.
- 13. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
None listed.
About this study
This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Standard cyclophosphamide, Goserelin (Zoladex)
- Keywords
- Early Stage Breast Cancer, Reduce Ovarian Failure Following Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cyclophosphamideDrug
AC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos)
Goserelin (Zoladex)Drug
Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo
| Study group | Role | What they receive |
|---|---|---|
| cyclophosphamide | Active comparator | Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy Receives: Drug: Standard cyclophosphamide |
| Goserelin (Zoladex) | Experimental | Goserelin (Zoladex) plus Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy Receives: Drug: Goserelin (Zoladex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adher Al Sayed, MD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530607
- Sponsor's protocol ID
- 2091-013
- Status last verified
- Feb 2012
- First submitted
- 23 Jan 2012
- Last updated
- 25 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01530607
- Acronym / sponsor ID
- 2091-013
- Conditions
- Breast Cancer
- Keywords
- Early Stage Breast Cancer, Reduce Ovarian Failure Following Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyclophosphamide | Active comparator | Drug: Standard cyclophosphamideStandard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy |
| Goserelin (Zoladex) | Experimental | Drug: Goserelin (Zoladex)Goserelin (Zoladex) plus Standard cyclophosphamide containing adjuvant or neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patients must be premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, or IIIA invasive breast cancer. Patients who have completed surgery must have pathologic Stage I, II, or IIIa disease. Patients to be treated in the preoperative setting may be staged clinically but must have operable disease. For the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and estradiol levels in the premenopausal range.
- Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative.
- Patients must be of age 18 or greater and under age 50.
- The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
- For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard cyclophosphamideAC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos) | Drug | cyclophosphamide |
| Goserelin (Zoladex)Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo | Drug | Goserelin (Zoladex) |
Primary outcome
The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
Adher Al Sayed, MD principal investigator
King Faisal Specialist Hospital & Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard cyclophosphamide and Goserelin (Zoladex) in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center.
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 13 inclusion and 0 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: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy (time frame: Three years). 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 25 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.