Clinical Trials Logo
  1. Home
  2. HER2-negative Breast Cancer
  3. NCT04498793

Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer

HER2-negative Breast Cancer Clinical Trial

Official title:
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as Perioperative Treatment in Participants With HER2 Negative Breast Cancer

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab plus chemotherapy vs chemotherapy alone as perioperative treatment in participants who have triple negative HER2 negative breast cancer.

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Tislelizumab + Chemotherapy OR Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment.

After definitive surgery, each participant will receive adjuvant study treatment (routine adjuvant treatment +/- Tislelizumab) for approximately 42 weeks (14 cycles).

Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04498793
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Hongnan Mo
Phone +861087788120
Email mhnzlyynk@outlook.com
Status Not yet recruiting
Phase Phase 2
Start date September 2020
Completion date December 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Completed NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT05173103 - Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01705691 - Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer Phase 2
Terminated NCT01368263 - Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer Phase 2
Recruiting NCT04576143 - Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer Phase 2/Phase 3
Completed NCT05054374 - A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT05467891 - Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer Phase 2
Recruiting NCT04660435 - To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Completed NCT02015559 - Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus Phase 2
Completed NCT04504916 - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002) Phase 2
Terminated NCT04738292 - Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) Phase 2
Recruiting NCT05982093 - Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer Phase 2
Recruiting NCT05396612 - Role of the Immune Environment in Response to Therapy in Breast Cancer
Active, not recruiting NCT04595565 - Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Phase 3
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2