Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02544243
• Other study ID #: ShandongCHI-05
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 22, 2015
• Last updated: September 5, 2015
• Start date: September 2015

Study information

• Verified date: September 2015
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong Yu, PhD
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Shandong Provincial Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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, 100 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 Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed metastatic breast cancer

• All patients were required to give written informed consent

• To have received a previous treatment with anthracyclines and taxanes

• Previous radiotherapy is allowed, whenever the radiated area is not the only disease location

• At least 4 weeks since the last previous antineoplastic treatment

• Patients must have recovered from all previous toxicities

• Karnofsky Performance status >= 70%

• Adequate hematological, renal, cardiac and hepatic function

• Life expectancy of at least 12 weeks

• Patients able to comply and to receive an adequate follow-up

Exclusion Criteria:

• Only bone metastases

• Active infection

• Previous treatment with one of the study drugs

• Application of other cytotoxic chemotherapy

• Insufficient renal function (creatinine clearance < 60ml/min)

• Clinically unstable brain metastasis

• Pregnancy or lactation

• Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)

• Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted

• Males

• Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Vinorelbine

• Gemcitabine

• Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months	No
Secondary	Overall Survival		Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months	No
Secondary	Clinical Benefit Rate		Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months	No
Secondary	Duration of response		Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months	No
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS). All patients who received at least one dose of study treatment will be included in the safety analysis.	Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months	Yes