A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib Carelizumab Plus Nab-paclitaxel and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    780
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 24 January 2021
paclitaxel
cancer
measurable disease
breast cancer
advanced breast cancer
HER2
solid tumour
triple negative breast cancer
stage iv breast cancer
erbb2
locally advanced breast cancer
apatinib
triple-negative breast cancer

Summary

This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).

Details
Condition Breast Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Breast Cancer Diagnosis, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, breast carcinoma, cancer, breast
Treatment Nab-paclitaxel, apatinib, Carelizumab
Clinical Study IdentifierNCT04335006
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ECOG Performance Status of 0-1
Expected lifetime of not less than three months
Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection
No prior systemic antitumor therapy for metastatic triple-negative breast cancer
Adequate hematologic and organ function
Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

Exclusion Criteria

Known central nervous system (CNS) disease
Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody
A history of bleeding, any serious bleeding events
Uncontrolled pleural effusion, pericardial effusion
Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
History of interstitial pneumonitis
Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc
Prior allogeneic stem cell or solid organ transplantation
History of autoimmune disease
Active hepatitis B or hepatitis C
Pregnancy or lactation
Peripheral neuropathy grade 2
Participants with poor blood pressure control
Myocardial infarction incident within 6 months prior to randomisation
Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note