Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT02140437
First received: May 9, 2014
Last updated: May 19, 2014
Last verified: May 2014

May 9, 2014
May 19, 2014
March 2014
December 2015   (final data collection date for primary outcome measure)
PFS(Progression free survival) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02140437 on ClinicalTrials.gov Archive Site
OS(overall survival ) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
  • 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 ]
Same as current
 
Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma Breast Stage IV
  • Drug: Fulvestrant
    Adding fulvestrant to the standard endocrine therapy, anastrozole
    Other Name: falsodex
  • Drug: Anastrozole
    standard endocrine therapy
    Other Name: Arimidex
  • Experimental: Fulvestrant and anastrozole
    Anastrozole 1 mg PO QD Fulvestrant 500mg IM d1,15, 29 and 4 weeks after
    Interventions:
    • Drug: Fulvestrant
    • Drug: Anastrozole
  • Active Comparator: Anastrozole
    Anastrozole 1 mg PO QD
    Intervention: Drug: Anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
June 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed informed consent
  2. Histologically confirmed breast cancer
  3. Luminal A-like breast cancer (primary or metastatic tumor), defined as: ER-positive, PR-positive (> 20%), Her-2 negative and Ki67 <14%.
  4. 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.
  5. 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.
  6. 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
  7. ECOG 0, 1 or 2.
  8. Patients with good compliance.
  9. Must be able to swallow tablets.
  10. Without any significant gastrointestinal obstruction or dysfunction of absorption for oral drug.

Exclusion Criteria:

  1. 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.
  2. Have received any systemic treatment other than first-line cytotoxic chemotherapy.
  3. Radiation therapy within 28 days prior to randomization (exception: radiotherapy to control bone pain, but should be completed before the randomization).
  4. Use any other anti-cancer therapy at the same time (except bisphosphonate).
  5. Previous endocrine treatment for advanced breast cancer.
  6. Current or previous malignancy ( except for breast cancer, basal cell or squamous cell carcinoma of the skin with adequate treatment, cervical carcinoma in situ).
  7. 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).
  8. History with hemorrhagic constitution (e.g. disseminated intravascular coagulation, clotting factor deficiency) or long-term anticoagulant therapy.
  9. Hypersensitivity history to excipients or castor oil of fulvestrant or anastrozole.
  10. Any other severe co-existing medical disorders, ie uncontrolled heart disease.
  11. Participation in any clinical trial and / or exposure to any investigational medication within 28 days before randomization.
Female
18 Years to 80 Years
No
Contact: Xichun HU, MD.PhD. +86-21-64175590 ext 85006 huxcun@gmail.com
Contact: Leiping Wang, MD.PhD +86-21-64175590 ext 88907 leipingwang@163.com
China
 
NCT02140437
Fudan BR 2014-14
Yes
Xichun Hu, Fudan University
Fudan University
Not Provided
Principal Investigator: Xichun Hu, MD.PhD. Fudan University
Fudan University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP