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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02163694




Registration number
NCT02163694
Ethics application status
Date submitted
19/05/2014
Date registered
16/06/2014
Date last updated
23/02/2024

Titles & IDs
Public title
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
Scientific title
A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Secondary ID [1] 0 0
2014-000345-70
Secondary ID [2] 0 0
M12-914
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Veliparib Placebo
Treatment: Drugs - Veliparib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Active Comparator: Veliparib Placebo with Carboplatin and Paclitaxel - Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

Experimental: Veliparib with Carboplatin and Paclitaxel - Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.


Treatment: Drugs: Veliparib Placebo
Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

Treatment: Drugs: Veliparib
Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

Treatment: Drugs: Carboplatin
Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.

Treatment: Drugs: Paclitaxel
Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 8 years from randomization
Secondary outcome [2] 0 0
Clinical Benefit Rate (CBR)
Timepoint [2] 0 0
Through the end of Week 24
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Approximately 8 years from randomization
Secondary outcome [4] 0 0
Progression-Free Survival on Subsequent Therapy (PFS2)
Timepoint [4] 0 0
Approximately 8 years from randomization

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed breast cancer that is either locally
advanced or metastatic. Locally advanced breast cancer must not be amenable to
surgical resection or radiation with curative intent.

2. Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer
Gene 2 (BRCA2) germline mutation.

3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative.

4. Measurable or non-measurable (but radiologically evaluable) disease per Response
Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT)
scan (within 28 days of randomization) with at least one lesion outside previously
irradiated areas.

5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.

6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin,
capecitabine) for metastatic disease.

- Regimens received in the adjuvant/neoadjuvant setting or for locally advanced
breast cancer within the past 6 months will also be considered toward the maximum
of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer
event will count as one prior line of therapy, if received within the past 6
months.

- Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and
signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab)
are allowed and are not counted towards the prior line of therapy.

2. Progressed or recurred within 12 months of completing platinum therapy or received > 1
prior line of platinum therapy for breast cancer in any setting (adjuvant,
neoadjuvant, or metastatic).

3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors.

4. Prior taxane therapy administered for the treatment of metastatic breast cancer with
the below exceptions.

- Prior taxane therapy for metastatic breast cancer is allowed if the patient
received = 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects
receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for
subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of
progression or if taxane therapy for metastatic disease was > 12 months prior to
Cycle 1 Day-2 (C1D-2).

- Use of taxanes as adjuvant therapy or to treat locally advanced disease is
permitted, if given more than 6 months prior to C1D-2

5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant
Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also
known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

6. Active CNS metastases or leptomeningeal disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2024
Sample size
Target
Accrual to date
Final
509
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital /ID# 129416 - Kogarah
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Duplicate_The Prince of Wales Hospital /ID# 124845 - Randwick
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Southern Medical Day Care Centre /ID# 124844 - Wollongong
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Townsville University Hospital /ID# 126731 - Douglas
Recruitment hospital [5] 0 0
Duplicate_Flinders Centre for Innovation /ID# 127535 - Bedford Park
Recruitment hospital [6] 0 0
Royal Hobart Hospital /ID# 124849 - Hobart
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital /ID# 124846 - Parkville
Recruitment hospital [8] 0 0
Hollywood Private Hospital /ID# 124843 - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick
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2500 - Wollongong
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4814 - Douglas
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5042 - Bedford Park
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7000 - Hobart
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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?????? ???
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to assess the progression-free survival (PFS) of
veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P
in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal
Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast
cancer. The secondary objectives of the study are to assess overall survival (OS), clinical
benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on
subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P
versus placebo in combination with C/P.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02163694
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT02163694