The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01506609 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 10, 2012
Last Update Posted
: February 14, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Drug: Placebo Drug: Veliparib Drug: Carboplatin Drug: Temozolomide Drug: Paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 294 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer |
Actual Study Start Date : | January 23, 2012 |
Estimated Primary Completion Date : | August 10, 2018 |
Estimated Study Completion Date : | August 10, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Veliparib with Temozolomide
Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
|
Drug: Veliparib
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
Other Name: ABT-888
Drug: Temozolomide
Days 1 through 5 of 28-day cycle (in combination with veliparib).
Other Name: Temodal
|
Placebo Comparator: Placebo with Carboplatin and Paclitaxel
Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
|
Drug: Placebo
Placebo comparator for Veliparib days 1 through 7 of 21-day cycle (in combination with carboplatin and/or paclitaxel).
Drug: Carboplatin
Day 3 of 21-day cycle
Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol
|
Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
|
Drug: Veliparib
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
Other Name: ABT-888
Drug: Carboplatin
Day 3 of 21-day cycle
Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol
|
- Progression -Free Survival [ Time Frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle ]
- Overall Survival [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]
- Clinical Benefit Rate (CBR) [ Time Frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation ]
- Objective Response Rate [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]
- Chemotherapy-Induced Peripheral Neuropathy (CIPN) [ Time Frame: From Cycle 1 Day 1 for subjects on the carboplatin and paclitaxel treatment arm, through 30 Day Follow-up Visit. ]CIPN (as assessed by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
- Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
- If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
- Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must not be pregnant or plan to conceive a child.
Exclusion Criteria:
- Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1
- More than 2 prior lines of cytotoxic chemotherapy
- Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
- Prior taxane therapy for metastatic breast cancer.
- A history of or evidence of brain metastases or leptomeningeal disease.
- A history of uncontrolled seizure disorder
- Pre-existing neuropathy from any cause in excess of Grade 1
- Known history of allergic reaction to cremophor/paclitaxel
- Clinical significant uncontrolled conditions â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
- Pregnant or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506609

United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, Arizona | |
Banner MD Anderson Cancer Ctr | |
Gilbert, Arizona, United States, 85234 | |
United States, Arkansas | |
Univ Arkansas Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Cedars-Sinai Medical Center | |
Beverly Hills, California, United States, 90211 | |
The Angeles Clinic and Researc | |
Los Angeles, California, United States, 90025 | |
Cedars-Sinai Medical Ctr | |
Los Angeles, California, United States, 90048 | |
UCSD | |
San Diego, California, United States, 92122 | |
Stanford Univ School of Med | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Lynn Cancer Institute, Boca | |
Boca Raton, Florida, United States, 33486 | |
Holy Cross Hospital | |
Fort Lauderdale, Florida, United States, 33308 | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
Florida Cancer Specialists | |
West Palm Beach, Florida, United States, 33401 | |
United States, Illinois | |
University of Illinois | |
Chicago, Illinois, United States, 60607 | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
Rush Univ Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Midwestern Regional Med Ctr | |
Zion, Illinois, United States, 60099 | |
United States, Maryland | |
Johns Hopkins | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
William Beaumont Hospital | |
Royal Oak, Michigan, United States, 48073 | |
United States, Missouri | |
Washington Univ School Med | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Beth Israel Medical Center | |
New York, New York, United States, 10003 | |
Memorial Sloan-Kettering Cance | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Penn State, Milton Hershey Med | |
Hershey, Pennsylvania, United States, 17033 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
UPMC | |
Pittsburgh, Pennsylvania, United States, 15260 | |
United States, South Carolina | |
Med Univ of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Tennessee | |
The West Clinic | |
Memphis, Tennessee, United States, 38120 | |
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75235 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
Argentina | |
COIBA | |
Berazategui, Buenos Aires, Argentina, 1884 | |
ISIS Centro Especializado | |
Santa Fe, Argentina, 3000 | |
Australia, New South Wales | |
The Prince of Wales Hospital | |
Randwick, New South Wales, Australia, 2031 | |
Southern Medical Day Care Ctr | |
Wollongong, New South Wales, Australia, 2500 | |
Australia, Queensland | |
Mater Health Hospital | |
South Brisbane, Queensland, Australia, 4101 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Tasmania | |
Royal Hobart Hospital | |
Hobart, Tasmania, Australia, 7000 | |
Australia, Victoria | |
Peter MacCallum Cancer Ctr | |
Melbourne, Victoria, Australia, 3050 | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
Australia, Western Australia | |
Mount Hospital | |
Perth, Western Australia, Australia, 6000 | |
Belgium | |
AZ St-Jan Brugge-Oostende AV | |
Brugge, Belgium, 8000 | |
Cliniques Univ. Saint Luc | |
Brussels, Belgium, 1200 | |
Grand Hopital de Charleroi | |
Charleroi, Belgium, 6000 | |
UZ Antwerp | |
Edegem, Belgium, 2650 | |
UZ Leuven | |
Leuven, Belgium, 3000 | |
CHU UCL Namur | |
Namur, Belgium, 5000 | |
Brazil | |
Hospital Bruno Born | |
Lajeado, Rio Grande Do Sul, Brazil, 95900-000 | |
Irmandade da Santa Casa de | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090 | |
Hosp Clinicas de Porto Alegre | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903 | |
Canada, Ontario | |
Sunnybrook Health Sciences Ctr | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Quebec | |
CHUM - Notre-Dame Hospital | |
Montreal, Quebec, Canada, H2L 4M1 | |
Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 | |
CHUQ-Hospital St. Sacrement | |
Quebec City, Quebec, Canada, G1S 4L8 | |
Czechia | |
Masarykuv onkologikcy ustav | |
Brno, Czechia, 656 53 | |
Palacky University | |
Olomouc, Czechia, 779 00 | |
Vseobecna Fakultni Nemocnice | |
Prague, Czechia, 128 08 | |
Denmark | |
Rigshospitalet, Finsen Centre | |
Copenhagen, Denmark, 2100 | |
Vejle Sygehus | |
Vejle, Denmark, 7100 | |
Finland | |
Docrates Cancer Center | |
Helsinki, Finland, 00180 | |
Tampere University Hospital | |
Tampere, Finland, 33521 | |
France | |
Hopital Universitaire Purpan - Hopital Pierre-Paul Riquet | |
Toulouse, Haute-Garonne, France, 31059 | |
Institut de Cancer de l'Ouest | |
St Herblain CEDEX, Loire-Atlantique, France, 44805 | |
Pays-Basque Ctr Oncology/Radio | |
Bayonne, France, 64100 | |
Centre Leon Berard | |
Lyon CEDEX 08, France, 69373 | |
Institut Paoli-Calmettes | |
Marseille, France, 13273 | |
Institut Curie | |
Paris, France, 75248 | |
Hopital Rene Huguenin | |
Saint-cloud, France, 92210 | |
Centre Paul Strauss | |
Strasbourg, France, 67065 | |
Hungary | |
Bajcsy-Zsilinszky Korhaz | |
Budapest, Hungary, 1106 | |
Debreceni Egyetem Klinikai Koz | |
Debrecen, Hungary, 4032 | |
Jasz-Nagykun-Szolnok Megyei | |
Szolnok, Hungary, 5004 | |
Israel | |
Soroka Medical Ctr | |
Be'er Sheva, Israel, 84101 | |
Assaf Harofeh Medical Center | |
Be'er Ya'akov, Israel, 70300 | |
Rambam Health Care Campus | |
Haifa, Israel, 3109601 | |
Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 | |
Hadassah University Hospital | |
Jerusalem, Israel, 91120 | |
Rabin Medical Center | |
Petah Tikva, Israel, 49100 | |
Sheba Medical Center | |
Ramat Gan, Israel, 5262100 | |
Kaplan Medical Center | |
Rehovot, Israel, 76100 | |
Netherlands | |
Erasmus Medisch Centrum | |
Rotterdam, Netherlands, 3015 CE | |
Norway | |
Haukeland University Hospital | |
Bergen, Norway, 5021 | |
Poland | |
Centrum Onkologii Lukaszczyka | |
Bydgoszcz, Poland, 85-796 | |
Olsztynski Osrodek Onkologi | |
Olsztyn, Poland, 10-513 | |
NZOZ Centrum Medyczne HCP | |
Poznan, Poland, 61-485 | |
Wielkopolskie Centrum Onkologi | |
Poznan, Poland, 61-866 | |
Mrukmed. Lekarz Beata Madej | |
Rzeszow, Poland, 35-922 | |
Romania | |
S.C. lanuli Med Consult SRL | |
Bucharest, Romania, 020962 | |
lnstitutul Oncologic Trestiore | |
Bucharest, Romania, 022328 | |
Spitalul Clinic Judetean de Ur | |
Cluj, Romania, 400006 | |
Inst Oncology Prof. Chiricuta | |
Cluj, Romania, 400010 | |
Sc Oncolab Srl | |
Craiova, Romania, 200385 | |
Russian Federation | |
Chelyabinsk Reg Clin Oncology | |
Chelyabinsk, Russian Federation, 454087 | |
NN Blokhin Russian Cancer | |
Moscow, Russian Federation, 115478 | |
Murmansk Regional Onc Dispens | |
Murmansk, Russian Federation, 183047 | |
City Clinical Hospital 1 | |
Novosibirsk, Russian Federation, 630075 | |
Pyatigorsk Oncology Dispensary | |
Pyatigorsk, Russian Federation, 357502 | |
St. Petersburg Healthcare | |
St. Petersburg, Russian Federation, 197183 | |
N.N. Petrov Research Inst Onc | |
St. Petersburg, Russian Federation, 197758 | |
Volgograd Reg Onc Disp #3 | |
Volzhsky, Russian Federation, 404130 | |
Spain | |
Hosp Santa Creu i Sant Pau | |
Barcelona, Spain, 08026 | |
Hospital Univ Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Genl Gregorio Maranon | |
Madrid, Spain, 28007 | |
Hosp Univ Madrid Sanchinarro | |
Madrid, Spain, 28050 | |
Hosp Uni Virgen de la Victoria | |
Malaga, Spain, 29010 | |
Hosp Clin Univ de Valencia | |
Valencia, Spain, 46010 | |
Sweden | |
Sahlgrenska University Hosp | |
Goteborg, Sweden, 413 45 | |
Skanes Universitetssjukhus | |
Malmo, Sweden, 205 02 | |
Karolinska Univ Sjukhuset | |
Solna, Sweden, 17176 | |
Ukraine | |
Cherkassy Regional Onc Ctr | |
Cherkasy, Ukraine, 18000 | |
City Multi-Field Clin Hosp #4 | |
Dnipropetrovsk, Ukraine, 49102 | |
Kharkiv Regional Clinical Onco | |
Kharkiv, Ukraine, 61070 | |
Lviv State Onc Local Treatment | |
Lviv, Ukraine, 79031 | |
Odessa National Medical Univ | |
Odesa, Ukraine, 65026 | |
Poltava Regional Clinical Onco | |
Poltava, Ukraine, 36011 | |
Sumy Reg Clinical Oncology Ctr | |
Sumy, Ukraine, 40005 |
Study Director: | AbbVie Inc. | AbbVie |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT01506609 History of Changes |
Other Study ID Numbers: |
M12-895 2011-002913-12 ( EudraCT Number ) |
First Posted: | January 10, 2012 Key Record Dates |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
PARP TMZ Temodal Carboplatin veliparib BRCA2 mutation carrier Breast cancer Metastatic breast cancer |
temozolomide BRCA1 mutation carrier ABT-888 Paclitaxel Recurrent breast cancer Temodar Locally recurrent |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Temozolomide Veliparib Albumin-Bound Paclitaxel Carboplatin Dacarbazine |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |