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

• ClinicalTrials.gov Identifier: NCT02546934
• Recruitment Status: Completed
• First Posted: September 11, 2015
• Last Update Posted: April 22, 2022
• Sponsor: Fudan University
• Information provided by (Responsible Party): Xichun Hu, Fudan University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: ABX, cisplatin; Drug: Gemcitabine, Cisplatin	Phase 3

Detailed Description:

A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 254 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer
• Study Start Date: March 2016
• Actual Primary Completion Date: April 2020
• Actual Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABX, cisplatin; AP (ABX and cisplatin combination)	Drug: ABX, cisplatin; ABX 125 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1; Other Name: experimental arm
Active Comparator: Gemcitabine, Cisplatin; GP (Gemcitabine and Cisplatin combination)	Drug: Gemcitabine, Cisplatin; Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1; Other Name: control arm

Outcome Measures

Primary Outcome Measures :

1. PFS (Progression Free Survival) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Objective Response Rate (ORR) [ Time Frame: 6 weeks ]
2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 weeks ]
3. Overall Survival (OS) [ Time Frame: 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 ]

Eligibility Criteria

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

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.

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

Contacts and Locations

Locations

China

Fudan University Cancer Hospital

Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Xichun Hu, MD, PhD; Fudan University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang B, Sun T, Zhao Y, Wang S, Zhang J, Wang Z, Teng YE, Cai L, Yan M, Wang X, Jiang Z, Pan Y, Luo J, Shao Z, Wu J, Guo X, Hu X. A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022 Jul 12;13(1):4025. doi: 10.1038/s41467-022-31704-7.

Wang B, Zhao Y, Li Y, Xu Y, Chen Y, Jiang Q, Yao D, Zhang L, Hu X, Fu C, Zhang S, Chen S. A plasma SNORD33 signature predicts platinum benefit in metastatic triple-negative breast cancer patients. Mol Cancer. 2022 Jan 18;21(1):22. doi: 10.1186/s12943-022-01504-0. No abstract available.

• Responsible Party: Xichun Hu, Dr, Fudan University
• ClinicalTrials.gov Identifier: NCT02546934
• Other Study ID Numbers: Fudan BR2015-18 CBCSG018
• First Posted: September 11, 2015
• Last Update Posted: April 22, 2022
• Last Verified: April 2022

Keywords provided by Xichun Hu, Fudan University:

triple negative breast cancer; fine line chemotherapy

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cisplatin; Gemcitabine; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action