Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

NCT02544243 | Unknown Phase 2

• 1 other identifier: ShandongCHI-05
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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, 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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• Incidence of Treatment-Emergent Adverse Events

  Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Vinorelbine; Drug: Gemcitabine

B

EXPERIMENTAL

Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks

Drug: Vinorelbine; Drug: Cisplatin

Interventions

Vinorelbine DRUG

A; B

Gemcitabine DRUG

A

Cisplatin DRUG

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zhiyong Yu, PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

• Xinzhao Wang, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Yu, PhD

CONTACT

86-13355312277; drzhiyongyu@aliyun.com

Xinzhao Wang, MD

CONTACT

86-15154156639; 08wangxinzhao@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Breast Surgery Ⅰ

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2017
• Last Updated: September 9, 2015

Record last verified: 2015-09