Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Vinorelbine; Drug: DDP

Detailed Description

Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xichun Hu, MD, PhD; Phone Number: 5006 64175590; Email: huxicun@gmail.com
• Study Contact Backup: Name: Zhonghua Wang, MD; Phone Number: 5000 64175590; Email: zhonghuawang95@hotmail.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Cancer Hospital
    • Contact: Xichun Hu, MD,PhD; Phone Number: 5006 64175590; Email: huxicun@gmail.com
    • Contact: Zhonghua Wang, MD; Phone Number: 5000 64175590; Email: zhonghuawang95@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. Performance status no more than 2
3. Life expectancy longer than 3 months
4. Histological proven unresectable recurrent or advanced breast cancer
5. 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+).
6. 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).
7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
8. Radiation therapy within 4 weeks prior to enrollment
9. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
10. Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

1. Patients had prior treatment with vinorelbine
2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
3. 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
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
6. Uncontrolled serious infection
7. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vinorelbine Plus DDP; Vinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days	Drug: Vinorelbine; 25 mg/m2, D1, D8; Other Names: NVB; Drug: DDP; 75 mg/m2, D1
Active Comparator: Vinorelbine; Vinorelbine:30 mg/m2, D1, D8 every 21 days	Drug: Vinorelbine; 25 mg/m2, D1, D8; Other Names: NVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS)	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: Fudan BR2015-19