Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer

NCT02000193 | Unknown Phase 2 DMC

• 1 other identifier: ISSFASL0042
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  1 year

• Objective Response Rate(ORR)

  1 year

• Number of Participants with Adverse Events

  1 year

Study Arms (1)

1

EXPERIMENTAL

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

Drug: fulvestrant

Interventions

fulvestrant DRUG

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.

Also known as: Faslodex

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• AstraZeneca: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• shusen wang, professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: December 4, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

CN (1)