Clinical trial · Interventional

Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer

Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine

NCT00480597CI-TRIAL-00004070completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
capecitabine	Drug	Capecitabine	ALIAS
cisplatin	Drug	Cisplatin	ALIAS
gemcitabine	Drug	Gemcitabine	ALIAS
vinorelbine	Drug	Vinorelbine	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Response rate
timeFrame
one year after last patient in

Secondary outcomes (3)

measure
Time to progression
timeFrame
one year after last patient in
measure
Overall Survival
timeFrame
one year after last patient in
measure
Toxicity

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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).

References

Publications (1)

DERIVEDHoon 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. PMID 34037241