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Trial record 8 of 317 for:    BENDAMUSTINE

Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer (MBC-6)

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: NCT01891227
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Tracking Information
First Submitted Date  ICMJE June 27, 2013
First Posted Date  ICMJE July 3, 2013
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE August 9, 2013
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01891227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
  • 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.
  • 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
  • Progression free survival [ Time Frame: 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer
Official Title  ICMJE Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    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 Name: Xeloda
  • Drug: Bendamustine
    Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
    Other Name: Levact
Study Arms  ICMJE 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.

Interventions:
  • Drug: Capecitabine
  • Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01891227
Other Study ID Numbers  ICMJE AGMT_MBC-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Sponsor  ICMJE Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Greil, Prof.Dr. Universitätsklinik für Innere Medizin III, Salzburg
PRS Account Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP