Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

• Sponsor: Shandong Cancer Hospital and Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04143906
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 62.2

Study Details

Study Description

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;

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Vinorelbine; Drug: Gemcitabine; Drug: Carboplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin
• Anticipated Study Start Date: Oct 25, 2019
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vinorelbine/Carboplatin Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks	Drug: Vinorelbine; injection; Drug: Carboplatin; injection
Experimental: Gemcitabine/Carboplatin Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks	Drug: Gemcitabine; injection; Drug: Carboplatin; injection

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shandong Cancer Hospital and Institute

Investigators

• Study Chair: Zhiyong Yu, PhD, Shandong Cancer Hospital and Institute
• Principal Investigator: Liang Zhang, MD, Shandong Cancer Hospital and Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhiyong Yu, Director of the Breast Surgery, Shandong Cancer Hospital and Institute
• ClinicalTrials.gov Identifier: NCT04143906
• Other Study ID Numbers: Shandong CHI-10
• First Posted: Oct 30, 2019
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhiyong Yu, Director of the Breast Surgery, Shandong Cancer Hospital and Institute: MBC, Vinorelbine, Carboplatin, Gemcitabine, PFS
• Additional relevant MeSH terms: Breast Neoplasms; Gemcitabine; Carboplatin; Vinorelbine

Study Results

No Results Posted as of Oct 30, 2019