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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02140437
Recruitment Status : Withdrawn (The progress of enrollment is too slow.)
First Posted : May 16, 2014
Last Update Posted : December 29, 2015
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma Breast Stage IV Drug: Fulvestrant Drug: Anastrozole Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fulvestrant and anastrozole
Anastrozole 1 mg PO QD Fulvestrant 500mg IM d1,15, 29 and 4 weeks after
Drug: Fulvestrant
Adding fulvestrant to the standard endocrine therapy, anastrozole
Other Name: falsodex

Drug: Anastrozole
standard endocrine therapy
Other Name: Arimidex

Active Comparator: Anastrozole
Anastrozole 1 mg PO QD
Drug: Anastrozole
standard endocrine therapy
Other Name: Arimidex

Primary Outcome Measures :
  1. PFS(Progression free survival) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. OS(overall survival ) [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. ORR(objective response rate) [ Time Frame: 8 weeks ]
  2. CBR(Clinical benefit rate) [ Time Frame: 8 weeks ]
  3. Number of patients with grade 3 or 4 adverse events [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02140437

Sponsors and Collaborators
Fudan University
Principal Investigator: Xichun Hu, MD.PhD. Fudan University

Responsible Party: Xichun Hu, M.D. Ph. D., Fudan University Identifier: NCT02140437     History of Changes
Other Study ID Numbers: Fudan BR2014-14
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Xichun Hu, Fudan University:
Luminal A-like
Advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
GABA Modulators
GABA Agents