Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

NCT02607215 | Unknown Phase 2

• 1 other identifier: Fudan BR2015-19
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  6 weeks

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  6 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  6 weeks

• Overall Survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (2)

Vinorelbine Plus DDP

EXPERIMENTAL

Vinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days

Drug: Vinorelbine; Drug: DDP

Vinorelbine

ACTIVE COMPARATOR

Vinorelbine:30 mg/m2, D1, D8 every 21 days

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

25 mg/m2, D1, D8

Also known as: NVB

Vinorelbine; Vinorelbine Plus DDP

DDP DRUG

75 mg/m2, D1

Vinorelbine Plus DDP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with age between 18 and 70 years old
• Performance status no more than 2
• Life expectancy longer than 3 months
• Histological proven unresectable recurrent or advanced breast cancer
• 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+).
• Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose).
• At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
• Radiation therapy within 4 weeks prior to enrollment
• All patients enrolled are required to have adequate hematologic, hepatic, and renal function
• Be able to understand the study procedures and sign informed consent.

You may not qualify if:

• Patients had prior treatment with vinorelbine
• Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
• 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
• Treatment with an investigational product within 4 weeks before the first treatment
• Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
• Uncontrolled serious infection
• Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD, PhD

CONTACT

64175590; huxicun@gmail.com

Zhonghua Wang, MD

CONTACT

64175590; zhonghuawang95@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 17, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)