Trial Condition(s):
Breast Cancer
Phase III Trial Comparing Capecitabine in Combination with Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
Bayer Identifier:
12444
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.
Inclusion Criteria
- Age is >=18 years - Subject has histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast. HER2 status should be determined by an accredited laboratory - Subject has locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. Must have measurable or non-measurable disease (according to RECIST [Response Evaluation Criteria for Solid Tumors] 1.1) - All computer tomography (CT; with contrast) and magnetic resonance imaging (MRI) used to document disease must have been done <= 4 weeks before randomization. Bone scans (if clinically indicated) must have been done <= 12 weeks prior to randomization - Subject must have received up to two prior chemotherapy regimens (adjuvant/neo-adjuvant treatments are considered one regimen), and no more than one prior regimen for advanced and/or metastatic disease. Chemotherapy regimens include both targeted and biologic therapy - Prior regimens must have included an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel), either in combination or in separate regimens, in either the neo-adjuvant/adjuvant or the metastatic setting or both, as either monotherapy or as part of a combination with another agent. Sequential regimens will count as a single regimen; multiple neo-adjuvant / adjuvant regimens will count as a single regimen - Subjects are either resistant to or have failed prior taxane and anthracycline OR Resistant to or have failed prior taxane AND for whom further anthracycline therapy is not indicated (for example, intolerance or cumulative doses of doxorubicin or doxorubicin equivalents [for example, epirubicin) - Subjects who relapse beyond 12 months after the last taxane or anthracycline dose given in the adjuvant, neo-adjuvant, or metastatic setting are eligible. Further therapy with the agent(s) for a subsequent regimen must have been considered and ruled out, for example due to prior toxicity or intolerance, or based on the local standard of practice - Prior experimental chemotherapy treatment is allowed, provided it is given in combination with at least one drug approved for the treatment of breast cancer (excluding drugs that target VEGF [Vascular Endothelial Growth Factor] or VEGFR [Vascular Endothelial Growth Factor Receptor], eg, bevacizumab, brivanib, sunitinib, vatalinib). - Prior hormonal therapy for locally advanced or metastatic breast cancer is allowed. Subjects who are refractory to hormonal therapy are allowed. - Prior neo-adjuvant or adjuvant chemotherapy is allowed. - Subject must have discontinued prior chemotherapy (including both targeted and biologic therapies), prior therapeutic radiation therapy, or prior hormonal therapy for locally advanced or metastatic disease >= 4 weeks (28 days) before randomization. Start of study treatment is allowed within less than 28 days of the prior therapy provided that 5 half-lives of the prior treatment drug(s) have elapsed - ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 - Adequate bone marrow, liver and renal function within 7 days prior to randomization - All acute toxic effects of any prior treatment have resolved to NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) v4.0 Grade 1 or less - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization - Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF (Informed Consent Form) until at least 30 days after the last dose of study drug. - Subject must be able to swallow and retain oral medication
Exclusion Criteria
- HER2 positive breast cancer - Unknown hormone receptor status (estrogen and progesterone receptor). - Subjects with bilateral breast cancer or a history of two distinct breast cancers. - Subjects with inflammatory breast carcinoma. - Subjects who have received no prior taxane and anthracycline for the treatment of breast cancer (either in adjuvant, neo-adjuvant or metastatic setting). - Prior use of sorafenib or capecitabine - Subjects considered by the treating investigator to be appropriate candidates for hormonal therapy as current treatment for locally advanced/metastatic breast cancer - Subjects with locally advanced disease who are considered by the treating investigator to be appropriate candidates for radiation therapy as current treatment for locally advanced breast cancer - Subjects with active brain metastases or leptomeningeal disease. - Subjects with seizure disorder requiring medication. - Radiation to any lesions <= 4 weeks prior to randomization. Palliative radiation to bone metastasis for pain control is permitted with provisions - Major surgery, open biopsy, or significant traumatic injury <= 4 weeks - Evidence or history of bleeding diathesis or coagulopathy. Uncontrolled hypertension, active or clinically significant cardiac disease. Subject with thrombotic, embolic, venus or arterial events - Subjects with any hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks before randomization - Subjects with an infection of NCI-CTCAE v4.0 > Grade 2 - Subjects with a history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection. - Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John’s Wort [Hypericum perforatum], dexamethasone at a dose of greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) within 28 days before randomization. - Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer - Subjects with a history DHPD (Dihydropyrimidine dehydrogenase) reaction to fluropyrimidine or history of known or suspected allergy or hypersensitivity to any of the study drugs - Presence of a non-healing wound, non-healing ulcer, or bone fracture - Women pregnant or breast feeding - Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greenbrae, United States, 94904-2007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9372212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mar del Plata, Argentina, B7600CTO | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site West Palm Beach, United States, 33407 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUGGE, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Terrassa, Spain, 08221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lleida, Spain, 25198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reus, Spain, 43204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo, Japan, 113-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kita-Adachigun, Japan, 362-0806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 791-0280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 811-1395 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 540-0006 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, DUBLIN 4 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 61-485 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdynia, Poland, 81-519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 5, Czech Republic, 150 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Olomouc, Czech Republic, 775 20 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chelyabinsk, Russia, 454087 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Castellón de la Plana, Spain, 12002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szentes, Hungary, 6600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site TOULOUSE, France, 31052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425AWC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bendigo, Australia, 3550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13589 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 128 08 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Galway, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H2L 4M1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, 9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 51067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Springfield, United States, 65804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Juan, United States, 00918 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Evansville, United States, 47713 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3G 1A4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United States, 37620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joliet, United States, 60435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site El Paso, United States, 79905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, United States, 05405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60389 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 39202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND CEDEX 1, France, 63011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SAINT CLOUD, France, 92210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, 7 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Port Elizabeth, South Africa, 6045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nova Ves Pod Plesi, Czech Republic, 262 04 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02115-6084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Shenyang, China, 110001 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Madrid, Spain, 28050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kagoshima, Japan, 892-0833 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase III Randomized, Double blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.Timeframe: From randomization of the first participant until approximately 3 years or until disease radiological progression
Secondary Outcome
- Overall Survival (OS)OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.Timeframe: From randomization of the first participant until approximately 3 years later
- Time to Progression (TTP) by Central ReviewTTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
- Objective Response Rate (ORR) by Central ReviewORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
- Disease Control Rate (DCR) by Central ReviewDCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
- Duration of Response (DOR) by Central ReaderDOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.Timeframe: From randomization of the first participant until approximately 3 years later or until disease radiological progression
Additional Information
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