Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

NCT ID: NCT04517292

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-08
• Study Completion Date: 2022-10-31

Brief Summary

Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

Detailed Description

A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.

Conditions

Breast Cancer

Study Design

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

Study Groups

Eribulin,cisplatin

EP (Eribulin and cisplatin combination)

Group Type: EXPERIMENTAL

Eribulin,cisplatin

Intervention Type: DRUG

Eribulin 1.4mg/m2, IV , D1, D8；Cisplatin 75 mg/m2, IV，D1

Gemcitabine,cisplatin

GP (gemcitabine and cisplatin combination)

Group Type: ACTIVE_COMPARATOR

Gemcitabine,cisplatin

Intervention Type: DRUG

Gemcitabine 1250 mg/m2, IV , D1, D8； Cisplatin 75 mg/m2, IV, D1

Interventions

Eribulin,cisplatin

Eribulin 1.4mg/m2, IV , D1, D8；Cisplatin 75 mg/m2, IV，D1

Intervention Type: DRUG

Gemcitabine,cisplatin

Gemcitabine 1250 mg/m2, IV , D1, D8； Cisplatin 75 mg/m2, IV, D1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Females with age between 18 and 70 years old

2. Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.

3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.

4. No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.

5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)

6. Performance status no more than 1

7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function

8. Life expectancy longer than 12 weeks

9. No serious medical history of heart, lung, liver and kidney

10. Be able to understand the study procedures and sign informed consent.

11. Patients with good compliance.

Exclusion Criteria

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)

2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study

3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy

4. Treatment with an investigational product within 4 weeks before the first treatment

5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration

6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions

8. Uncontrolled serious infection

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

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhang,MD

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer center

Shanghai, , China

Countries

China

Central Contacts

Jian Zhang, MD,PhD

Role: CONTACT

syner2000@163.com

8664175590 ext. 85000

Yiqun Du, MD,PhD

Role: CONTACT

dyqlh2010@163.com

8664175590 ext. 85000

Facility Contacts

Jian Zhang, MD,PhD

Role: primary

syner2000@163.com

+8664175590 ext. 85000

Yiqun Du, MD,PhD

Role: backup

dyqlh2010@163.com

+8664175590 ext. 85000

Other Identifiers

GEP

Identifier Type: -

Identifier Source: org_study_id