Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

NCT04143906 | Unknown Phase 2

• 1 other identifier: Shandong CHI-10
• 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; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;

Conditions

Metastatic Breast Cancer

Keywords

MBC, Vinorelbine, Carboplatin, Gemcitabine, PFS

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)

Vinorelbine/Carboplatin

EXPERIMENTAL

Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks

Drug: Vinorelbine; Drug: Carboplatin

Gemcitabine/Carboplatin

EXPERIMENTAL

Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks

Drug: Gemcitabine; Drug: Carboplatin

Interventions

Vinorelbine DRUG

injection

Vinorelbine/Carboplatin

Gemcitabine DRUG

injection

Gemcitabine/Carboplatin

Carboplatin DRUG

injection

Gemcitabine/Carboplatin; Vinorelbine/Carboplatin

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; Carboplatin

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; Coordination Complexes; Organic Chemicals

Study Officials

• Zhiyong Yu, PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

• Liang Zhang, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Yu, PhD

CONTACT

86-13355312277; drzhiyongyu@aliyun.com

Liang Zhang, MD

CONTACT

86-15165035280; zhang.liang1992@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

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 30, 2019
• Study Start: October 25, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 30, 2019

Record last verified: 2019-10