Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC
Verified September 2015 by Fudan University
Information provided by (Responsible Party):
Xichun Hu, Fudan University
First received: May 9, 2014
Last updated: September 6, 2015
Last verified: September 2015
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.
Carcinoma Breast Stage IV
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- PFS(Progression free survival) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- OS(overall survival ) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- ORR(objective response rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- CBR(Clinical benefit rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Number of patients with grade 3 or 4 adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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 Name: falsodex
standard endocrine therapy
Other Name: Arimidex
Active Comparator: Anastrozole
Anastrozole 1 mg PO QD
standard endocrine therapy
Other Name: Arimidex
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02140437
|Fudan University Shanghai Cancer Center
|Shanghai, Shanghai, China, 200032 |
|Contact: Xichun Hu, MD.PhD. 862164175590 ext 85001 firstname.lastname@example.org |
|Principal Investigator: Xichun Hu, MD.PhD. |
||Xichun Hu, MD.PhD.
No publications provided
||Xichun Hu, M.D. Ph. D., Fudan University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 9, 2014
||September 6, 2015
||China: Food and Drug Administration
Keywords provided by Fudan University:
Advanced breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Neoplasms by Site
Antineoplastic Agents, Hormonal
Estrogen Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs