Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Status

Closed

Cancer Type

Breast Cancer

Trial Phase

Phase III

Eligibility

18 - 99 Years, Male and Female

Study Type

Treatment

NCT ID

NCT02000622

Protocol IDs

D0819C00003 (primary)
2013-005137-20

Study Sponsor

AstraZeneca Pharmaceuticals LP

NCI Full Details

http://clinicaltrials.gov/show/NCT02000622

Summary

This open label, randomised, controlled, multi-centre phase III study will assess the
efficacy and safety of single agent olaparib vs standard of care based on physician's choice
of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2
mutations.

Objectives

Primary Outcome Measures:

Progression Free Survival by BICR using RECIST 1.1. [ Time Frame: Assessed when approx 75% patients have experienced objective disease progression by RECIST. RECIST assessments performed at baseline, every 6 wks for the first 6 mths, then every 12 wks until progression. Data collection will last up to approx 7 years. ] [ Designated as safety issue: No ]
Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of progression free survival (PFS) using blinded independent central review (BICR) data assessed by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Secondary Outcome Measures:

Overall Survival [ Time Frame: Assessed at time of PFS analysis and when approx 60% patients have died by any cause (on average 15 months after randomisation). Survival assessed every 8 weeks following objective disease progression. Data collection will last up to approx 7 years. ] [ Designated as safety issue: No ]
Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of overall survival (OS). This assessment is performed until the time of the final OS analysis (when approximately 60% patients have died).
Time from randomisation to second progression or death (PFS2). [ Time Frame: Assessed at time of PFS analysis and at final OS analysis. After first objective disease progression by RECIST, patients will then be assessed every 8 weeks for second progression. Data collection will last up to approx 7 years. ] [ Designated as safety issue: No ]
Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of time to second progression, defined as objective radiological or symptomatic progression, or death (PFS2). This assessment is performed until the time of the final OS analysis (when approximately 60% patients have died).
Objective Response Rate by BICR using RECIST 1.1 [ Time Frame: Assessed at time of PFS analysis. RECIST assessments are performed at baseline, every 6 weeks for the first 6 months, then every 12 weeks until objective disease progression. Data collection will last up to approx 7 years. ] [ Designated as safety issue: No ]
Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of objective response rate (ORR) using BICR data assessed by RECIST 1.1.
Adjusted mean change from baseline in global QoL score from the EORTC-QLQ-C30 questionnaire. [ Time Frame: EORTC QLQ-C30 questionnaires to be completed at baseline and every 6 weeks until disease progression. Study data collection is expected to last up to approximately 7 years. ] [ Designated as safety issue: No ]
Assessment of the effect of olaparib on the Health-related Quality of Life (HRQoL) as measured by EORTC QLQ-C30 global QoL scale.
Safety and tolerability of olaparib by assessment of adverse events. [ Time Frame: Adverse events collected from informed consent until post treatment 30-day follow-up period. Study data collection is expected to last up to approximately 7 years. ] [ Designated as safety issue: Yes ]
Assessment of adverse events (AEs), graded by CTCAE (v4.0).
Safety and tolerability of olaparib by assessment of physical examination. [ Time Frame: Physical examinations carried out at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ] [ Designated as safety issue: Yes ]
Assessment of physical examination.
Safety and tolerability of olaparib by assessment of vital signs. [ Time Frame: Vital signs assessments collected at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ] [ Designated as safety issue: Yes ]
Assessment of vital signs including blood pressure (BP), pulse and electrocardiogram (ECG).
Safety and tolerability of olaparib by assessment of laboratory parameters. [ Time Frame: Laboratory parameter assessments collected at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ] [ Designated as safety issue: Yes ]
Assessment of laboratory parameters including clinical chemistry and haematology.

Eligibility

Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
ECOG performance status 0-1.
Adequate bone marrow, kidney and liver function.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell

1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen

200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton

157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville

100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville

6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper

1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta

340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Doctors:

Michael B. Andrews MD
Bruce J. Gould MD
Hillary A. Hahm MD, PhD
Carmen M. Klass MD, PhD
Steven L. McCune MD, PhD
Raul H. Oyola MD
Don W. Shaffer II MD, FACP
Dean M. Kirkel MD

Northwest Georgia Oncology Centers - Paulding

144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica

705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD

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