Metastatic Breast CancerPhase 2PROOFNCT02072512
The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
A Phase 2 study testing Fulvestrant, Goserelin and Anastrozole in people with Metastatic Breast Cancer, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Fulvestrant, Goserelin and Anastrozole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent document on file.
- All patients must be female with age>18 and premenopausal or perimenopausal.
- Patients must have an ECOG performance status of 0, 1, or 2.
- Patients with life expectancy of more than 3 months.
- Patients with metastatic or locally advanced disease not amenable to therapy with curative intent.
- Histological/cytological confirmation of breast cancer. Patients must have either positive estrogen and/or progesterone receptor determination by IHC or competitive binding assay on advanced disease, or if not performed on their advanced disease a positive result on their primary breast cancer specimen (Positivity is defined as an Allred score from 3 to 8 by IHC or at least 1% positive tumor nuclei in the sample in the presence of expected reactivity of internal and external controls [35]).
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- Patients who recurred on or after completion of adjuvant tamoxifen therapy(with or without GnRHa). Toremifene could be substituted for tamoxifen in adjuvant setting.
- Duration of adjuvant tamoxifen(toremifene) treatment should be at least 48 weeks or more.
- Patients with measurable lesion at baseline, or Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST 1.1 criteria
- Patients may receive irradiation to any bony sites of disease for pain control or for prevention of fracture.
- For women of childbearing potential, agreement to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment.
Who cannot join
- Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
- Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
- Age .60 years
- Prior bilateral oophorectomy
- Age<60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and estradiol in the postmenopausal range(according to local sites).
- If taking tamoxifen or toremifene, and age<60 years, then FSH and plasma estradiol level in postmenopausal ranges(according to local sites).
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- More than one regimen of chemotherapy for advanced disease.
- Previous endocrine therapy for advanced disease.
- Prior treatment with an aromatase inhibitor or fulvestrant.
- Prior treatment with a GnRHa within 3 months.
- Treatment with a non-approved or experimental drug within 4 weeks before randomisation.
- Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
- History of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency), or long-term anticoagulant therapy.
- Known hypersensitivity to the active substance or to any of the excipients of this product, or other GnRHa.
- HER-2 over-expressing breast cancer and concomitant trastuzumab treatment.
- Pregnancy and lactation.
- Any severe concomitant condition which makes it undesirable for the patient to participate in t he trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease, uncontrolled diabetes mellitus, severe osteoporosis or renal failure and so on .
- Inadequate organ function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
307 Hospital
Beijing, Beijing Municipality, 100071
Zefei Jiang, Ph.D, 8610-66947171, jiangzf@hotmail.com
Tao Wang, Ph.D, 8610-66947430, wangtao6@hotmail.com
About this study
The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer.
Read the detailed description
Premenopausal advanced breast cancer patients who failed tamoxifen treatment are possible good candidates for ovarian ablation/suppression and aromatase inhibitors.Fulvestrant has been studied little in premenopausal women despite of its attractive mechanism of actions. Based on this rationale, we introduced high-dose of fulvestrant with LHRH agonist as a randomized trial comparing with AI plus LHRH agonist.
To assess efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
- Conditions
- Metastatic Breast Cancer
- Being tested
- Fulvestrant, Goserelin, Anastrozole
- Keywords
- pre- and perimenopausal HR+ advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Fulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops
GoserelinDrug
goserelin 3.6mg subcutaneously every 28(± 3) days
AnastrozoleDrug
Anastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops
GoserelinDrug
goserelin 3.6mg subcutaneously every 28(± 3) days
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant | Active comparator | Goserelin plus High Dose Fulvestrant Receives: Drug: Fulvestrant; Drug: Goserelin |
| Anastrozole | Active comparator | Goserelin plus Anastrozole Receives: Drug: Anastrozole; Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
Primary endpoint is progression-free survival. Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause
Measured: Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause.Participants will be followed for an expected average of 1 year.
Secondary outcomes (2)
the overall response rate(by RECIST version 1.1) of patients treated with goserelin plus fulvestrant 500mg and the overall response rate of patients treated with goserelin plus anastrozole.
to compare overall response rate of patients treated with goserelin plus fulvestrant 500mg with overall response rate of patients treated with goserelin plus anastrozole.
Measured: Participants will be followed for an expected average of 1 year.
the clinical benefit rate of patients treated with goserelin plus fulvestrant 500mg and clinical benefit rate of patients treated with goserelin plus anastrozole.
Measured: Participants will be followed for an expected average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Affiliated to Military Medical Science, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zefei Jiang, Ph.D, Principal investigator, 307 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072512
- Sponsor's protocol ID
- 307BC ET-01
- Acronym
- PROOF
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02072512
- Acronym / sponsor ID
- PROOF / 307BC ET-01
- Conditions
- Metastatic Breast Cancer
- Keywords
- pre- and perimenopausal HR+ advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Affiliated to Military Medical Science, BeijingUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Feb 2014 (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.
The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer.
Detailed description
Premenopausal advanced breast cancer patients who failed tamoxifen treatment are possible good candidates for ovarian ablation/suppression and aromatase inhibitors.Fulvestrant has been studied little in premenopausal women despite of its attractive mechanism of actions. Based on this rationale, we introduced high-dose of fulvestrant with LHRH agonist as a randomized trial comparing with AI plus LHRH agonist.
To assess efficacy of goserelin plus fulvestrant 500mg comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant | Active comparator | Drug: Fulvestrant, Drug: GoserelinGoserelin plus High Dose Fulvestrant |
| Anastrozole | Active comparator | Drug: Anastrozole, Drug: GoserelinGoserelin plus Anastrozole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed informed consent document on file.
- All patients must be female with age>18 and premenopausal or perimenopausal.
- Patients must have an ECOG performance status of 0, 1, or 2.
- Patients with life expectancy of more than 3 months.
- Patients with metastatic or locally advanced disease not amenable to therapy with curative intent.
Key exclusion criteria (18 listed)
- Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
- Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
- More than one regimen of chemotherapy for advanced disease.
- Previous endocrine therapy for advanced disease.
- Prior treatment with an aromatase inhibitor or fulvestrant.
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 |
|---|---|---|
| FulvestrantFulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops | Drug | Fulvestrant |
| Goserelingoserelin 3.6mg subcutaneously every 28(± 3) days | Drug | Fulvestrant |
| AnastrozoleAnastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops | Drug | Anastrozole |
| Goserelingoserelin 3.6mg subcutaneously every 28(± 3) days | Drug | Anastrozole |
Primary outcome
the efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS)
Time frame: Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause.Participants will be followed for an expected average of 1 year.
Primary endpoint is progression-free survival. Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause
2 secondary outcomes
the overall response rate(by RECIST version 1.1) of patients treated with goserelin plus fulvestrant 500mg and the overall response rate of patients treated with goserelin plus anastrozole.
Time frame: Participants will be followed for an expected average of 1 year.
the clinical benefit rate of patients treated with goserelin plus fulvestrant 500mg and clinical benefit rate of patients treated with goserelin plus anastrozole.
Time frame: Participants will be followed for an expected average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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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.
Zefei Jiang, Ph.D principal investigator
307 Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant, Goserelin and Anastrozole in people with Metastatic Breast Cancer, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site in China.
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 11 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zefei Jiang, Ph.D (8610-66947171, jiangzf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of goserelin plus fulvestrant 500mg and the efficacy of goserelin plus anastrozole as first line endocrine therapy for pre- and perimenopausal HR+ advanced breast cancer in terms of progression-free survival(PFS) (time frame: Progression-free survival (PFS) is defined as the time elapsed between randomization and tumor progression(by RECIST version 1.1) or death from any cause.Participants will be followed for an expected average of 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 26 Feb 2014.