- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891227
Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer (MBC-6)
Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial
Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9 weeks.
Aim of this study is to determine whether treatment with capecitabine in combination with bendamustine is efficacious and safe.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
40 eligible patients will be enrolled. A two-stage design efficacy and safety of bendamustine and capecitabine will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited to reach the target population of 40 evaluable patients.
Pretreatment for eligible patients must include anthracyclines and/or taxanes.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Feldkirch, Austria, A-6807
- Hämatologie und Onkologie/Interne E, LKH Feldkirch
-
Graz, Austria, 8036
- Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie
-
Graz, Austria, 8036
- Universitätsklinik f. Innere Medizin, Klin.Abt. f. Onkologie
-
Innsbruck, Austria, A-6020
- Univ.-Klinik f. Frauenheilkunde; Klinische Abt. f. Gynäkologie u. Geburtshilfe
-
Linz, Austria, A-4010
- KH Barmh. Schwestern Linz, Innere Medizin I Hämatologie/Onkologie
-
Linz, Austria, A-4021
- Kepler Universitätsklinikum, Med Campus III, Klinik f. Interne 3 - Schwerpunkt Hämatologie u. Onkologie
-
Salzburg, Austria, A-5020
- Universitätsklinik für Innere Medizin III
-
Steyr, Austria, A-4400
- Landeskrankenhaus Steyr, Interne Medizin II
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- Female patients, age ≥ 18 years (women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception)
- Advanced or metastatic Her2-negative breast cancer, histologically confirmed
- At least one measurable lesion according to RECIST criteria (Version 1.1)
- Documented disease progression
- Patients with progression after anthracycline and/or taxane treatment(palliative or adjuvant)
- Life expectancy of at least 12 weeks
- Performance status 0-2
Hematologic:
- ANC (absolute neutrophil count) ≥ 1.5 x 109/L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100 x 109/L
Liver Function:
- Albumin ≥ 2.5 g/dL
- Serum bilirubin ≤ 2 mg/dL
AST (Aspartate aminotransferase) and ALT (Alanine aminotransferase) ≤ 3 x ULN (Upper limit of Normal) without liver metastases
- 5 x ULN if documented liver metastases
- Renal Function:
- Serum Creatinine ≤ 1.5 mg/dL OR Calculated Creatinine Clearance ≥ 40 mL/min
Exclusion Criteria:
- Pregnant or lactating women
- Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
- Radiation of the target lesion within the last 4 weeks
- Active bacterial, viral or fungal infection
- Patients with clinically apparent brain metastases
- Known Positivity for HIV
- Positivity for Hepatitis B or C
- History of other malignancy; patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Concurrent cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug
- Antihormonal therapy must have been discontinued prior to start of treatment (if possible at least 3 weeks before)
- Known hypersensitivity to the study drugs capecitabine and bendamustine or their excipients
- Pretreatment with capecitabine (pretreatment with infusional 5-FU (Fluorouracil) in the adjuvant or neoadjuvant setting is allowed) or bendamustine
- Treatment with sorivudine or derivates e.g. brivudin (Mevir©) within the last 4 weeks before and during study treatment with capecitabine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capecitabine and Bendamustine
Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects). Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles). Eligible patients will receive capecitabine in combination with bendamustine for a maximum of eight cycles and afterwards capecitabine mono will be continued until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals; efficacy assessments will be conducted every 9 weeks. |
Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
Other Names:
Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of capecitabine + bendamustine combination regimen
Time Frame: At baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
Overall response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors - RECIST (Response Evaluation Criteria In Solid Tumors) Version 1.1) The study will be stopped after 20 patients if there are fewer than four subjects with an overall response of CR (complete response) or PR (partial response). If there are at least four responses an additional 20 subjects will be enrolled and treated till a maximum of 40 subjects. The regimen is concluded to be effective if 13 or more responses out of 40 are observed at the end of the trial. The last patient is expected to enter the study in Q1 2015, following a 24 month recruitment period. Last Subject Last Visit will be at final staging after end of treatment of last patient. Follow-up after Last Subject Last Visit will be conducted according to local standard of care thereafter, and is not part of study procedures. |
At baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety profile of a combination with capecitabine and bendamustine
Time Frame: From treatment start until 28 days after last study treatment; expected study duration 3 years
|
To determine the safety profile of a combination with capecitabine and bendamustine in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to progression or for any other reason.
All safety analyses will be based on the safety population, defined as subjects who received at least one dose of the study medication and have at least one post-treatment safety assessment available.
The safety population will be used for all safety and tolerability analyses including demographic data, vital signs, laboratory data and adverse events.
|
From treatment start until 28 days after last study treatment; expected study duration 3 years
|
Clinical benefit
Time Frame: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
CR, PR or stable disease for at least 24 weeks
|
Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
Progression free survival
Time Frame: Baseline + every 9 weeks until progression; expected study duration 3 years
|
Baseline + every 9 weeks until progression; expected study duration 3 years
|
|
Overall survival
Time Frame: During complete study treatment, after study treatment every 3 months until end of complete study; expected study duration 3 years
|
explorative, from treatment start until death from any cause
|
During complete study treatment, after study treatment every 3 months until end of complete study; expected study duration 3 years
|
Quality of life
Time Frame: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
To evaluate Quality of Life (QoL) status within the study population using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ (Quality-of-life-questionnaire)-C30 standard questionnaire and the BR23 module (module for breast cancer patients)
|
Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years
|
Predefined subgroup analysis in terms of response
Time Frame: Baseline + every 9 weeks until progression + at end of study treatment+every 3 months after end of treatment until end of study; expected study duration 3 years
|
Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of response
|
Baseline + every 9 weeks until progression + at end of study treatment+every 3 months after end of treatment until end of study; expected study duration 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Greil, Prof.Dr., Universitätsklinik für Innere Medizin III, Salzburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGMT_MBC-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Capecitabine
-
Sun Yat-sen UniversityChengdu Biostar PharmaceuticalsNot yet recruitingBreast Neoplasms | Locally Advanced or Metastatic Breast CancerChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
-
Binghe XuHoffmann-La RocheUnknownSkin Diseases | Neoplasms by Site | Breast Neoplasms | Breast Diseases | Neoplasm MetastasisChina
-
Jules Bordet InstituteCompletedBreast Cancer | Elderly PatientsBelgium
-
Samsung Medical CenterCompletedAdvanced or Recurrent Esophageal Squamous Cell CarcinomaKorea, Republic of
-
Fudan UniversityCompletedMetastatic Breast CancerChina
-
Cancer Institute and Hospital, Chinese Academy...Hoffmann-La RocheUnknownCarcinoma, Invasive Ductal, BreastChina
-
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
-
Jiangxi Provincial Cancer HospitalNot yet recruitingNasopharyngeal Carcinoma | Maintenance Therapy | High-Risk Cancer