Trial Outcomes & Findings for Retrospective Study Assessment Treatment Response Faslodex®( 500 mg) (NCT NCT01509625)

NCT ID: NCT01509625

Last Updated: 2016-06-01

Results Overview

Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Recruitment status: COMPLETED
• Target enrollment: 272 participants
• Primary outcome timeframe: 22 months
• Results posted on: 2016-06-01

Participant Flow

Participant milestones

Measure	One Arm of Metastatic Breast Cancer Patients All the patients have tumors with positive estrogen receptors
Overall Study STARTED	272
Overall Study COMPLETED	263
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

Baseline characteristics by cohort

Measure	One Arm of Metastatic RE Breast Cancer Patients n=272 Participants Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=93 Participants
Age, Categorical >=65 years	138 Participants n=93 Participants
Age, Continuous age	65 years n=93 Participants
Sex: Female, Male Female	272 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment Spain	272 participants n=93 Participants
Histologic type ductal	208 participants n=93 Participants
Histologic type lobulillar	37 participants n=93 Participants
Histologic type ductal+lobulillar	7 participants n=93 Participants
Histologic type others	7 participants n=93 Participants
Histologic type not known	13 participants n=93 Participants
Estrogen receptor and Progesterone receptor status ER positive and PGR positive	197 participants n=93 Participants
Estrogen receptor and Progesterone receptor status ER positive and PGR negative	61 participants n=93 Participants
Estrogen receptor and Progesterone receptor status ER negative and PGR positive	1 participants n=93 Participants
Estrogen receptor and Progesterone receptor status No specifical information	13 participants n=93 Participants

PRIMARY outcome

Timeframe: 22 months

Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=263 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis Group of patients with metastasis in organs like liver or lungs
Progression Free Survival	10.6 month Interval 9.0 to 11.5	—

SECONDARY outcome

Timeframe: 22 months

Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=263 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis Group of patients with metastasis in organs like liver or lungs
Clinical Benefit Rate	56.5 percentage of patients	—

SECONDARY outcome

Timeframe: 22 months

Response to treatment with fulvestrant in terms of Overall Survival

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=263 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis Group of patients with metastasis in organs like liver or lungs
Overall Survival	43.2 month Interval 37.0 to 49.2	—

SECONDARY outcome

Timeframe: 22 months

Population: For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140)

Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=140 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis Group of patients with metastasis in organs like liver or lungs
Duration of Clinical Benefit	18.4 month Interval 14.5 to 23.0	—

SECONDARY outcome

Timeframe: 22 months

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=263 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis Group of patients with metastasis in organs like liver or lungs
Number of Participants With Adverse Events any toxicity	35.4 percentage of patients Interval 29.6 to 41.5	—
Number of Participants With Adverse Events local pain injection	9.9 percentage of patients Interval 6.6 to 14.1	—
Number of Participants With Adverse Events Muscle-bone pain	7.2 percentage of patients Interval 4.4 to 11.1	—
Number of Participants With Adverse Events Gastrointestinals disorders	6.8 percentage of patients Interval 4.1 to 10.6	—
Number of Participants With Adverse Events Hot flashes	6.1 percentage of patients Interval 3.5 to 9.7	—
Number of Participants With Adverse Events Urinary infection	0.8 percentage of patients Interval 0.1 to 2.7	—
Number of Participants With Adverse Events Weight gain	0.8 percentage of patients Interval 0.0 to 2.1	—
Number of Participants With Adverse Events Vaginitis	0.4 percentage of patients Interval 0.0 to 2.1	—
Number of Participants With Adverse Events Joint pain	16 percentage of patients Interval 11.8 to 21.0	—

SECONDARY outcome

Timeframe: 22 months

Population: We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.

Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=225 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis n=38 Participants Group of patients with metastasis in organs like liver or lungs
Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases	10.6 month Interval 8.9 to 10.6	10 month Interval 7.1 to 13.9

SECONDARY outcome

Timeframe: 22 months

Population: We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups.

To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=128 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis n=130 Participants Group of patients with metastasis in organs like liver or lungs
Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy	11.2 month Interval 9.5 to 13.6	9.2 month Interval 7.4 to 11.2

SECONDARY outcome

Timeframe: 22 months

Population: We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients.

To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=26 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis n=206 Participants Group of patients with metastasis in organs like liver or lungs
Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2	10.2 month Interval 7.7 to 13.3	10.3 month Interval 8.0 to 11.3

SECONDARY outcome

Timeframe: 22 months

Population: We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients.

To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups

Outcome measures

Measure	One Arm of Metastatic Breast Cancer Patients n=70 Participants All patients have tumors with positive estrogen receptors	Patients With Visceral Metastasis n=72 Participants Group of patients with metastasis in organs like liver or lungs
Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67	9.6 month Interval 6.5 to 13.1	10.0 month Interval 7.8 to 12.9

Adverse Events

One Arm of Metastatic Breast Cancer Patients

Serious events: 0 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	One Arm of Metastatic Breast Cancer Patients n=263 participants at risk All patients have tumors with positive estrogen receptors
Gastrointestinal disorders Gastrointestinal disorders	6.8% 18/263 • 6 months
Injury, poisoning and procedural complications Pain in inyection site	9.9% 26/263 • 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal disorders	7.2% 19/263 • 6 months
Skin and subcutaneous tissue disorders Hot flushes	6.1% 16/263 • 6 months
Infections and infestations Urinary infection	0.76% 2/263 • 6 months
Endocrine disorders Weight gain	0.38% 1/263 • 6 months
Infections and infestations Vaginitis	0.38% 1/263 • 6 months
Musculoskeletal and connective tissue disorders Joint pain	16.0% 42/263 • 6 months

Additional Information

Dr Isabel Blancas

Hospital Clínico San Cecilio Granada

Phone: +34 958023498

Email: blancaslb@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place