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New treatment option for Triple Negative Breast Cancer
Official title Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
ClinicalTrials.gov ID: NCT05447702
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Newly diagnosed breast cancer.
- 18-75 Years, female.
- Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
- Tumor stage: II-III.
- ECOG Performance Status of 0-1.
You likely can't join if
- Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer.
- Inflammatory breast cancer.
- Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy...
- Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent...
- Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer...
- Major surgical procedure within 4 weeks prior to initiation of study treatment.
See the full eligibility criteria
- Newly diagnosed breast cancer.
- 18-75 Years, female.
- Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
- Tumor stage: II-III.
- ECOG Performance Status of 0-1.
- life expectancy is not less than 3 months.
- at least one measurable lesion according to RECIST 1.1.
- Adequate hematologic and organ function.
- Must be willing to use an adequate method of contraception for the course of the study.
- Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer.
- Inflammatory breast cancer.
- Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TAE.
- Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor...
- Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Major surgical procedure within 4 weeks prior to initiation of study treatment.
- Has a history of autoimmune disease.
- Has a history of hypertension that not well controlled by antihypertensive treatment
- Has a history of myocardial infarction, severe/unstable angina pectoris, NYHA Class 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart...
- Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases.
- Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis.
- Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment.
- Has evidence of active tuberculosis within 1 year prior to initiation of study treatment.
- Prior allogeneic stem cell or solid organ transplantation.
- Peripheral neuropathy grade ≥2.
- Has clinically significant intestinal obstruction.
- Arterial/venous thrombosis events that occurred within 3 months before enrollment, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism.
- Has hemoptysis symptoms within 2 months before enrollment and the maximum daily hemoptysis ≥ 2.5 ml.
- Clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment.
- Has known genetic or acquired bleeding or thrombotic tendency.
- Abnormal coagulation (INR\>1.5 or APTT\>1.5 x ULN) with bleeding tendency, receiving thrombolysis or anticoagulation therapy, or requiring long-term antiplatelet therapy.
- Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- Any other situation evaluated by researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.