- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140437
Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC
December 24, 2015 updated by: Xichun Hu, Fudan University
An Open-label, Multi-center, Randomized Phase II Study of Fulvestrant Anastrozole Combination Versus Anastrozole Alone in Patients With Luminal A-like Postmenopausal Advanced Breast Cancer
This research is designed to investigate whether the addition of fulvestrant 500mg to anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced breast cancer.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Anastrozole is the standard first-line endocrine treatment for patients with hormonal receptor positive advanced breast cancer.
It has been proven that the addition of fulvestrant 250mg can enhance PFS of anastrozole monotherapy according to SWOG0226 study.
However, the optimal recommended dose of fulvestrant for patients with advanced breast cancer is 500mg worldwide according to CONFIRM study.
The investigator designed this research to investigate whether high dose fulvestrant can further improve efficacy of anastrozole monotherapy.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Signed informed consent
- Histologically confirmed breast cancer
- Luminal A-like breast cancer (primary or metastatic tumor), defined as: ER-positive, PR-positive (> 20%), Her-2 negative and Ki67 <14%.
Advanced breast cancer is eligible:
- Endocrine therapy-naive patients with locally advanced disease, who are not suitable for radical surgery or radiotherapy (the decision made by the multidisciplinary breast cancer team). Prior first-line cytotoxic chemotherapy is acceptable. or
- Patients with recurrent or metastatic disease, who have not received adjuvant endocrine therapy or who have been 2 years or longer after stop of adjuvant endocrine therapy. Patients who had disease progression from first-line cytotoxic chemotherapy are allowed.
- At least one lesion (measurable and / or non-measurable) can be assessed at baseline, and is suitable for repeated assessments with CT and/or MRI.
Postmenopausal women, defined as any one of the following criteria (as defined in the NCCN's menopause definition):
- previous bilateral oophorectomy
- 60 years old or older
- less than 60 years old, amenorrheic for 12 months or longer in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone and estradiol in the postmenopausal range.
- If taking tamoxifen, or toremifene and age < 60, then FSH and E in the postmenopausal range
- ECOG 0, 1 or 2.
- Patients with good compliance.
- Must be able to swallow tablets.
- Without any significant gastrointestinal obstruction or dysfunction of absorption for oral drug.
Exclusion Criteria:
- Life-threatening metastatic visceral disease, defined as extensive liver involvement or any degree of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymphatic metastasis. If the investigator believe that their respiratory function is not significantly impaired due to illness, patients with scattered parenchymal metastases are qualified.
- Have received any systemic treatment other than first-line cytotoxic chemotherapy.
- Radiation therapy within 28 days prior to randomization (exception: radiotherapy to control bone pain, but should be completed before the randomization).
- Use any other anti-cancer therapy at the same time (except bisphosphonate).
- Previous endocrine treatment for advanced breast cancer.
- Current or previous malignancy ( except for breast cancer, basal cell or squamous cell carcinoma of the skin with adequate treatment, cervical carcinoma in situ).
- Inadequate blood or liver or renal function within one week prior to randomization: Platelets < 80 × 10^9/L; Total bilirubin > 1.5 × (ULRR) (patients with Gilbert's syndrome is eligible); or ALT or AST > 2.5 × ULRR (without liver metastases) or > 5 × ULRR (with liver metastases).
- History with hemorrhagic constitution (e.g. disseminated intravascular coagulation, clotting factor deficiency) or long-term anticoagulant therapy.
- Hypersensitivity history to excipients or castor oil of fulvestrant or anastrozole.
- Any other severe co-existing medical disorders, ie uncontrolled heart disease.
- Participation in any clinical trial and / or exposure to any investigational medication within 28 days before randomization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fulvestrant and anastrozole
Anastrozole 1 mg PO QD Fulvestrant 500mg IM d1,15, 29 and 4 weeks after
|
Adding fulvestrant to the standard endocrine therapy, anastrozole
Other Names:
standard endocrine therapy
Other Names:
|
Active Comparator: Anastrozole
Anastrozole 1 mg PO QD
|
standard endocrine therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS(Progression free survival)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OS(overall survival )
Time Frame: 8 weeks
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ORR(objective response rate)
Time Frame: 8 weeks
|
8 weeks
|
CBR(Clinical benefit rate)
Time Frame: 8 weeks
|
8 weeks
|
Number of patients with grade 3 or 4 adverse events
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xichun Hu, MD.PhD., Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
May 9, 2014
First Submitted That Met QC Criteria
May 15, 2014
First Posted (Estimate)
May 16, 2014
Study Record Updates
Last Update Posted (Estimate)
December 29, 2015
Last Update Submitted That Met QC Criteria
December 24, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Anastrozole
Other Study ID Numbers
- Fudan BR2014-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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