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Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

S

Shandong First Medical University

Status and phase

Not yet enrolling
Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: Gemcitabine
Drug: Carboplatin
Drug: Vinorelbine

Study type

Interventional

Funder types

Other

Identifiers

NCT04143906
Shandong CHI-10

Details and patient eligibility

About

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;

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Liang Zhang, MD; Zhiyong Yu, PhD

Data sourced from clinicaltrials.gov

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