Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

NCT ID: NCT04143906

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinorelbine/Carboplatin

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

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

injection

Carboplatin

Intervention Type: DRUG

injection

Gemcitabine/Carboplatin

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

injection

Carboplatin

Intervention Type: DRUG

injection

Interventions

Vinorelbine

injection

Intervention Type: DRUG

Gemcitabine

injection

Intervention Type: DRUG

Carboplatin

injection

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Yu

Director of the Breast Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiyong Yu, PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Liang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

Zhiyong Yu, PhD

Role: CONTACT

drzhiyongyu@aliyun.com

86-13355312277

Liang Zhang, MD

Role: CONTACT

zhang.liang1992@163.com

86-15165035280

Other Identifiers

Shandong CHI-10

Identifier Type: -

Identifier Source: org_study_id