SWOG clinical trial number
CTSU/NSABP B-55
A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy.
Closed
Phase
Abbreviated Title
Olaparib v. Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer
Status Notes
Permanent Closure - Effective 4/29/19.
Permanent Closure Part 1 and 2 Screening: Anticipated Effective 4/1/2019.
It is anticipated that accrual to the NSABP B-55/BIG
6-13 trial may reach the global accrual goal of 1800 patients in April 2019. Therefore, the closure of Part 1 and Part 2 Screening is likely to occur on April 1, 2019 with randomization closing on April 29, 2019. The study team is monitoring accrual closely and will update sites in the coming weeks with the final screening and randomization closure dates. Please continue to screen patients who have the potential to be randomized by April 29th.
Permanent Closure Part 1 and 2 Screening: Anticipated Effective 4/1/2019.
It is anticipated that accrual to the NSABP B-55/BIG
6-13 trial may reach the global accrual goal of 1800 patients in April 2019. Therefore, the closure of Part 1 and Part 2 Screening is likely to occur on April 1, 2019 with randomization closing on April 29, 2019. The study team is monitoring accrual closely and will update sites in the coming weeks with the final screening and randomization closure dates. Please continue to screen patients who have the potential to be randomized by April 29th.
Activated
07/03/2014
Closed
04/29/2019
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
Research committees
Breast Cancer
Treatment
Olaparib
Eligibility Criteria Expand/Collapse
SWOG is participating in this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.
Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.
Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.
Other Clinical Trials
SWOG Clinical Trial Number
CTSU-A012303
Shortstop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer who Achieve PCR After Neoadjuvant Chemotherapy with HER2 Blockade
Research Committee(s)
Breast Cancer
Activated
07/25/2025
Open
SWOG Clinical Trial Number
CTSU-A012301
LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer
Research Committee(s)
Breast Cancer
Activated
02/05/2025
Open
Phase
SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
29%
Open
Phase