Clinical trial NCT00480597: Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Official title: Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: gemcitabine
vinorelbine
cisplatin
capecitabine
pretreated metastatic breast cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2007-05-31
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.

For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* All patients were required to give written informed consent
* Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
* Antracycline-pretreatment during aduvant or palliative first line therapy
* Bidimensionally measurable lesion outside a previous radiation field.
* Age \>= 18 years
* Karnofsky Performance status \>= 70%
* Adequate heamatological, renal, cardiac and hepatic function
* No radiation of the measurable lesion during the study was allowed.

Exclusion Criteria:

* Only bone metastases
* Active infection
* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy
* Insufficent renal function (creatinine clearance \< 60ml/min)
* Known DPD deficiency
* clinically unstable brain metastasis
* pregancy or lactation
* other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).

Primary outcomes:
measure: Response rate
timeFrame: one year after last patient in
Secondary outcomes:
measure: Time to progression
timeFrame: one year after last patient in
measure: Overall Survival
timeFrame: one year after last patient in
measure: Toxicity
Other outcomes:
Locations:
Study officials:
affiliation: University of Munich - Klinikum Grosshadern
name: Volker Heinemann, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.