The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
Information source: Hospital Affiliated to Military Medical Science, Beijing
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: Fulvestrant (Drug); Goserelin (Drug); Anastrozole (Drug); Goserelin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hospital Affiliated to Military Medical Science, Beijing Official(s) and/or principal investigator(s): Zefei Jiang, Ph.D, Principal Investigator, Affiliation: 307 Hospital of PLA
Overall contact: Zefei Jiang, Ph.D, Phone: 8610-66947171, Email: jiangzf@hotmail.com
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.
Clinical Details
Official title: The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Secondary outcome: 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.the clinical benefit rate of patients treated with goserelin plus fulvestrant 500mg and clinical benefit rate of patients treated with goserelin plus anastrozole.
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Signed informed consent document on file.
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:
1. 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.
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
Locations and Contacts
Zefei Jiang, Ph.D, Phone: 8610-66947171, Email: jiangzf@hotmail.com
307 Hospital, Beijing, Beijing 100071, China; Recruiting Zefei Jiang, Ph.D, Phone: 8610-66947171, Email: jiangzf@hotmail.com Tao Wang, Ph.D, Phone: 8610-66947430, Email: wangtao6@hotmail.com
Additional Information
Starting date: January 2014
Last updated: February 24, 2014
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