The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
NCT ID: NCT02072512
Last Updated: 2014-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fulvestrant
Goserelin plus High Dose Fulvestrant
Fulvestrant
Fulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops
Goserelin
goserelin 3.6mg subcutaneously every 28(± 3) days
Anastrozole
Goserelin plus Anastrozole
Anastrozole
Anastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops
Goserelin
goserelin 3.6mg subcutaneously every 28(± 3) days
Interventions
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Fulvestrant
Fulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops
Goserelin
goserelin 3.6mg subcutaneously every 28(± 3) days
Anastrozole
Anastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops
Goserelin
goserelin 3.6mg subcutaneously every 28(± 3) days
Eligibility Criteria
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Inclusion Criteria
2. All patients must be female with age\>18 and premenopausal or perimenopausal.
3. Patients must have an ECOG performance status of 0, 1, or 2.
4. Patients with life expectancy of more than 3 months.
5. Patients with metastatic or locally advanced disease not amenable to therapy with curative intent.
6. 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 \[35\]).
7. Patients who recurred on or after completion of adjuvant tamoxifen therapy(with or without GnRHa). Toremifene could be substituted for tamoxifen in adjuvant setting.
8. Duration of adjuvant tamoxifen(toremifene) treatment should be at least 48 weeks or more.
9. 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
10. Patients may receive irradiation to any bony sites of disease for pain control or for prevention of fracture.
11. 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.
Exclusion Criteria
2. 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).
3. More than one regimen of chemotherapy for advanced disease.
4. Previous endocrine therapy for advanced disease.
5. Prior treatment with an aromatase inhibitor or fulvestrant.
6. Prior treatment with a GnRHa within 3 months.
7. Treatment with a non-approved or experimental drug within 4 weeks before randomisation.
8. 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).
9. History of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency), or long-term anticoagulant therapy.
10. Known hypersensitivity to the active substance or to any of the excipients of this product, or other GnRHa.
11. HER-2 over-expressing breast cancer and concomitant trastuzumab treatment.
12. Pregnancy and lactation.
13. 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 .
14. Inadequate organ function
18 Years
60 Years
ALL
No
Sponsors
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Hospital Affiliated to Military Medical Science, Beijing
OTHER
Responsible Party
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Principal Investigators
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Zefei Jiang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
307 Hospital of PLA
Locations
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307 Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307BC ET-01
Identifier Type: -
Identifier Source: org_study_id
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