Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: Vinorelbine; Drug: Carboplatin

• Registration Number: NCT04143906
• Lead Sponsor: Shandong Cancer Hospital and Institute

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;

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-25
• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-27
• Last Update Submitted: 2019-10-27
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Histologically confirmed metastatic breast cancer;
2. All patients were required to give written informed consent;
3. To have received a previous treatment with anthracyclines and taxanes;
4. Previous radiotherapy is allowed, whenever the radiated area is not the only disease location;
5. At least 4 weeks since the last previous antineoplastic treatment;
6. Patients must have recovered from all previous toxicities;
7. Karnofsky Performance status >= 70%;
8. Adequate hematological, renal, cardiac and hepatic function;
9. Life expectancy of at least 12 weeks;
10. Patients able to comply and to receive an adequate follow-up;

Exclusion Criteria

1. Only bone metastases;
2. Active infection;
3. Previous treatment with one of the study drugs;
4. Application of other cytotoxic chemotherapy;
5. Insufficient renal function (creatinine clearance < 60ml/min);
6. Clinically unstable brain metastasis;
7. Pregnancy or lactation;
8. Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin);
9. 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;
10. Males;
11. 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vinorelbine/Carboplatin	Carboplatin	Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Gemcitabine/Carboplatin	Gemcitabine	Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Vinorelbine/Carboplatin	Vinorelbine	Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Gemcitabine/Carboplatin	Carboplatin	Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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	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.