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Breast CancerPhase 2MBC-6NCT01891227

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

A Phase 2 study testing Capecitabine and Bendamustine in people with Breast Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Capecitabine and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
8 sitesAustria
Study dates
9 Aug 2013to 15 Mar 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Austria8 sites

  • Hämatologie und Onkologie/Interne E, LKH Feldkirch

    Feldkirch, A-6807

  • Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie

    Graz, 8036

  • Universitätsklinik f. Innere Medizin, Klin.Abt. f. Onkologie

    Graz, 8036

  • Univ.-Klinik f. Frauenheilkunde; Klinische Abt. f. Gynäkologie u. Geburtshilfe

    Innsbruck, A-6020

  • KH Barmh. Schwestern Linz, Innere Medizin I Hämatologie/Onkologie

    Linz, A-4010

  • Kepler Universitätsklinikum, Med Campus III, Klinik f. Interne 3 - Schwerpunkt Hämatologie u. Onkologie

    Linz, A-4021

  • Universitätsklinik für Innere Medizin III

    Salzburg, A-5020

  • Landeskrankenhaus Steyr, Interne Medizin II

    Steyr, A-4400

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Keywords
Bendamustine, Capecitabine, Pretreated, Her2 negative, Advanced breast cancer, Metastatic breast cancer, Anthracycline pretreatment, Taxane pretreatment
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Xeloda

    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).

  • BendamustineDrug

    Also called Levact

    Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).

Study groups in NCT01891227
Study groupRoleWhat they receive
Capecitabine and BendamustineExperimentalCapecitabine 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.
Receives: Drug: Capecitabine; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of capecitabine + bendamustine combination regimen

    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.

    Measured: At baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years

Secondary outcomes (6)

  1. Safety profile of a combination with capecitabine and bendamustine

    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.

    Measured: From treatment start until 28 days after last study treatment; expected study duration 3 years

  2. Clinical benefit

    CR, PR or stable disease for at least 24 weeks

    Measured: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years

  3. Progression free survival

    Measured: Baseline + every 9 weeks until progression; expected study duration 3 years

  4. Overall survival

    explorative, from treatment start until death from any cause

    Measured: During complete study treatment, after study treatment every 3 months until end of complete study; expected study duration 3 years

  5. Quality of life

    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)

    Measured: Baseline + every 9 weeks until progression + at end of study treatment; expected study duration 3 years

  6. Predefined subgroup analysis in terms of response

    Predefined subgroup analysis of triple-negative patients and hormone receptor positive patients in terms of response

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2013 (estimated)
  2. Study start9 Aug 2013
  3. Primary completion15 Mar 2018
  4. Study completion15 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01891227
Sponsor's protocol ID
AGMT_MBC-6
Acronym
MBC-6
Status last verified
Nov 2018
First submitted
27 Jun 2013
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • Rinnerthaler G, Gampenrieder SP, Petzer A, Hubalek M, Petru E, Sandholzer M, Andel J, Balic M, Melchardt T, Hauser-Kronberger C, Schmitt CA, Ulmer H, Greil R. Capecitabine in combination with bendamustine in pretreated women with HER2-negative metastatic breast cancer: results of a phase II trial (AGMT MBC-6). Ther Adv Med Oncol. 2021 Oct 19;13:17588359211042301. doi: 10.1177/17588359211042301. eCollection 2021.

    PubMed 34691243

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Bendamustine in people with Breast Cancer, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01891227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

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