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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Drug: Bendamustine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial
Actual Study Start Date : August 9, 2013
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Progression free survival [ Time Frame: Baseline + every 9 weeks until progression; expected study duration 3 years ]
  4. 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

  5. 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)

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01891227


Locations
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Austria
Hämatologie und Onkologie/Interne E, LKH Feldkirch
Feldkirch, Austria, A-6807
Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie
Graz, Austria, 8036
Universitätsklinik f. Innere Medizin, Klin.Abt. f. Onkologie
Graz, Austria, 8036
Univ.-Klinik f. Frauenheilkunde; Klinische Abt. f. Gynäkologie u. Geburtshilfe
Innsbruck, Austria, A-6020
KH Barmh. Schwestern Linz, Innere Medizin I Hämatologie/Onkologie
Linz, Austria, A-4010
Kepler Universitätsklinikum, Med Campus III, Klinik f. Interne 3 - Schwerpunkt Hämatologie u. Onkologie
Linz, Austria, A-4021
Universitätsklinik für Innere Medizin III
Salzburg, Austria, A-5020
Landeskrankenhaus Steyr, Interne Medizin II
Steyr, Austria, A-4400
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
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Principal Investigator: Richard Greil, Prof.Dr. Universitätsklinik für Innere Medizin III, Salzburg
More Information
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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01891227     History of Changes
Other Study ID Numbers: AGMT_MBC-6
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Bendamustine
Capecitabine
Pretreated
Her2 negative
 Advanced breast cancer
Metastatic breast cancer
Anthracycline pretreatment
Taxane pretreatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Bendamustine Hydrochloride
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents