A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02447328
• Collaborator: (none)
• Enrollment: 83
• Locations: 9
• Arm: 1
• Actual Duration (Months): 63.6
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or; Metastatic Breast Cancer	Drug: Fulvestrant	Phase 4

Detailed Description

This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer.

All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites.

After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.

Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
• Actual Study Start Date: May 29, 2015
• Actual Primary Completion Date: May 6, 2016
• Actual Study Completion Date: Sep 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm Faslodex treated in the study	Drug: Fulvestrant; fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.

Outcome Measures

Primary Outcome Measures

1. Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) [Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.]

   Percentage of patients with AEs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Post menopausal status women

• Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.

• Estrogen receptor positive

• Radiographic progression of disease after the prior therapy

• Patients who agree to participate in this study and sign the informed consent

Exclusion Criteria:

• Patients who are treated with fulvestrant

• Patients who are being treated with the other antitumor agents

• Pregnancy or lactating women

• History of hypersensitivity to any of included ingredients (eg. Castor oil)

• Patients who are considered not fit for the study by investigators

• Patients who have severe dysfunction of liver or kidney

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Cheongju-si		Korea, Republic of	28644
2	Research Site	Daegu		Korea, Republic of	41404
3	Research Site	Goyang-si		Korea, Republic of	10408
4	Research Site	Seo-Gu		Korea, Republic of	49241
5	Research Site	Seongnam-si		Korea, Republic of	13620
6	Research Site	Seoul		Korea, Republic of	03080
7	Research Site	Seoul		Korea, Republic of	03722
8	Research Site	Seoul		Korea, Republic of	06591
9	Research Site	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02447328
• Other Study ID Numbers: D6998L00004
• First Posted: May 18, 2015
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Breast Neoplasms; Fulvestrant

Study Results

Participant Flow

Recruitment Details	First subject enrolled: 29MAY2015 Last subject last visit: 06MAY2016 This study was conducted from 29 May 2015 to 06 May 2016 and 85 subjects from 9 study centres participated.
Pre-assignment Detail	Visit 1 (Enrolment visit) Obtained ICF and Eligibility check Duration of treatment with Fulvestrant (Faslodex®): Study drug administered biweekly at first cycle. Afterward, Study drug administered monthly. (expected duration of treatment: 6 cycles) End of Study post dose follow-up visit after study drug discontinuation.

Arm/Group Title	Single Arm
Arm/Group Description	fulvestrant (Faslodex®)
Period Title: Overall Study
STARTED	83
COMPLETED	82
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Single Arm
Arm/Group Description	fulvestrant (Faslodex®)
Overall Participants	81
Age (years) [Mean (Standard Deviation) ]
Age	56.6 (9.34)
Sex: Female, Male (Count of Participants)
Female	81 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Description	Percentage of patients with AEs.
Time Frame	Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.

Outcome Measure Data

Analysis Population Description

The safety population: All patients given at least one dose of the study treatment will be included. Data from this population will be used for the safety analysis.

Arm/Group Title	Single Arm
Arm/Group Description	fulvestrant (Faslodex®)
Measure Participants	81
Adverse Events(AE)	81.5 100.6%
ADR; based on current South Korea label.	38.3 47.3%
Serious AE	11.1 13.7%
Serious ADR	0 0%
Unexpected AE	71.6 88.4%
Unexpected ADR	24.7 30.5%

Adverse Events

Time Frame	6 months
Arm/Group Title	Single Arm
Arm/Group Description	fulvestrant (Faslodex®)
All Cause Mortality
	Single Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	9/81 (11.1%)
Hepatobiliary disorders
CHOLANGITIS	1/81 (1.2%)	1
Injury, poisoning and procedural complications
contusion of brain	1/81 (1.2%)	1
Joint Dislocation	1/81 (1.2%)	1
Investigations
Blood creatinine increased	1/81 (1.2%)	1
Musculoskeletal and connective tissue disorders
Bone Pain	1/81 (1.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia (in remission)	1/81 (1.2%)	1
Renal and urinary disorders
Hydronephrosis	1/81 (1.2%)	1
Reproductive system and breast disorders
pelvic pain	1/81 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	66/81 (81.5%)
Gastrointestinal disorders
nausea	10/81 (12.3%)	12
Constipation	7/81 (8.6%)	7
Anorexia	6/81 (7.4%)	6
Dyspepsia	5/81 (6.2%)	5
General disorders
back pain	9/81 (11.1%)	11
Pain	6/81 (7.4%)	6
fatigue	5/81 (6.2%)	5
Musculoskeletal and connective tissue disorders
Myalgia	10/81 (12.3%)	12
arthralgia	6/81 (7.4%)	6
Nervous system disorders
headache	7/81 (8.6%)	7
dizziness	9/81 (11.1%)	10
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection	6/81 (7.4%)	6
Dyspnea	5/81 (6.2%)	5
Skin and subcutaneous tissue disorders
pruritus	5/81 (6.2%)	5
rash	5/81 (6.2%)	5

Limitations/Caveats

less information in efficacy set.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

14.1 The Institution and the Principal Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Company's prior written consent.