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

NCT01891227 | Completed Phase 2

• 1 other identifier: AGMT_MBC-6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer

Keywords

Bendamustine; Capecitabine; Pretreated; Her2 negative; Advanced breast cancer; Metastatic breast cancer; Anthracycline pretreatment; Taxane pretreatment

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Safety profile of a combination with capecitabine and bendamustine

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

• Clinical benefit

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

• Progression free survival

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

• Overall survival

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

• Quality of life

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

Study Arms (1)

Capecitabine and Bendamustine

EXPERIMENTAL

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; Drug: Bendamustine

Interventions

Capecitabine DRUG

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).

Also known as: Xeloda

Capecitabine and Bendamustine

Bendamustine DRUG

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

Also known as: Levact

Capecitabine and Bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (8)

Hämatologie und Onkologie/Interne E, LKH Feldkirch

Feldkirch, A-6807, Austria

Location

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

Graz, 8036, Austria

Location

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

Graz, 8036, Austria

Location

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

Innsbruck, A-6020, Austria

Location

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

Linz, A-4010, Austria

Location

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

Linz, A-4021, Austria

Location

Universitätsklinik für Innere Medizin III

Salzburg, A-5020, Austria

Location

Landeskrankenhaus Steyr, Interne Medizin II

Steyr, A-4400, Austria

Location

Related Publications (1)

• 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.

  PMID: 34691243 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Richard Greil, Prof.Dr.

  Universitätsklinik für Innere Medizin III, Salzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 3, 2013
• Study Start: August 9, 2013
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

AU (8)