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Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer (FANCY)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fulvestrant
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent Histologically proven HR positive breast cancer

Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]):

Prior bilateral oophorectomy Age ≥60 years Age <60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and oestradiol in the postmenopausal range.

Patients have completed first-line chemotherapy for metastatic breast cancer The first-line chemotherapy must be given to patients with visceral disease or progressive disease requiring a fast response Responded(CR or PR) or stabilized(SD>=24 weeks) to first-line chemotherapy for metastatic breast cancer The duration of 1st line chemotherapy for advanced breast cancer had been at least 4 cycles and at most 8 cycles WHO performance status 0, 1 or 2-

Exclusion Criteria:

  • Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present) Prior hormonal treatment for metastatic breast cancer are not allowed More than one line of cytotoxic chemotherapy for metastatic breast cancer Her-2 positive Other malignant tumor (concurrent or previous). Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus

Sites / Locations

  • State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

drug: Fulvestrant treatment : Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, 29, then every 28 days. The treatment will continue until disease progression or intolerable adverse event

Outcomes

Primary Outcome Measures

Clinical Benefit Rate
defined as the proportion of all treated patients who have a best objective tumour response of CR, PR or SD ≥ 24 weeks

Secondary Outcome Measures

Progression Free Survival (PFS)
Objective Response Rate(ORR)
Number of Participants with Adverse Events

Full Information

First Posted
November 13, 2013
Last Updated
July 7, 2018
Sponsor
Sun Yat-sen University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02000193
Brief Title
Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer
Acronym
FANCY
Official Title
Maintenance Hormone Therapy With Fulvestrant After First-Line Chemotherapy for Postmenopausal Hormone-receptor-positive (HR) Positive Advanced Breast Cancer: A Multicenter, Prospective Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.
Detailed Description
This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer. Approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy. The treatment will continue until the objective disease progression or intolerable AE. Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST (Response Evaluation Criteria in Solid Tumors ) 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0. Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every 12 weeks for all patients until documented evidence of objective disease progression. Reporting of SAEs (serious adverse events) to regulatory authorities will be done by the investigator in accordance with local regulations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
drug: Fulvestrant treatment : Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, 29, then every 28 days. The treatment will continue until disease progression or intolerable adverse event
Intervention Type
Drug
Intervention Name(s)
fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, and 29， then every 28 days. The treatment will continue until disease progression or intolerable AE.
Primary Outcome Measure Information:
Title
Clinical Benefit Rate
Description
defined as the proportion of all treated patients who have a best objective tumour response of CR, PR or SD ≥ 24 weeks
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
1 year
Title
Objective Response Rate(ORR)
Time Frame
1 year
Title
Number of Participants with Adverse Events
Time Frame
1 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent Histologically proven HR positive breast cancer Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]): Prior bilateral oophorectomy Age ≥60 years Age <60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and oestradiol in the postmenopausal range. Patients have completed first-line chemotherapy for metastatic breast cancer The first-line chemotherapy must be given to patients with visceral disease or progressive disease requiring a fast response Responded(CR or PR) or stabilized(SD>=24 weeks) to first-line chemotherapy for metastatic breast cancer The duration of 1st line chemotherapy for advanced breast cancer had been at least 4 cycles and at most 8 cycles WHO performance status 0, 1 or 2- Exclusion Criteria: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present) Prior hormonal treatment for metastatic breast cancer are not allowed More than one line of cytotoxic chemotherapy for metastatic breast cancer Her-2 positive Other malignant tumor (concurrent or previous). Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shusen wang, professor
Organizational Affiliation
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Learn more about this trial

Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer

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