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

NCT ID: NCT01891227

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-09
• Study Completion Date: 2018-03-15

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: 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).

Bendamustine

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Bendamustine

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

Intervention Type: DRUG

Other Intervention Names

Xeloda; Levact

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Greil, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Innere Medizin III, Salzburg

Locations

Hämatologie und Onkologie/Interne E, LKH Feldkirch

Feldkirch, , Austria

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

Graz, , Austria

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

Graz, , Austria

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

Innsbruck, , Austria

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

Linz, , Austria

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

Linz, , Austria

Universitätsklinik für Innere Medizin III

Salzburg, , Austria

Landeskrankenhaus Steyr, Interne Medizin II

Steyr, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 34691243 (View on PubMed)

Other Identifiers

AGMT_MBC-6

Identifier Type: -

Identifier Source: org_study_id