New combo therapy shows promise for aggressive breast cancer in early trial
NCT ID NCT06817525
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a combination of chemotherapy drugs (nab-paclitaxel and carboplatin) plus an immunotherapy drug (Camrelizumab) given before surgery can eliminate all cancer in patients with early triple-negative breast cancer. About 64 participants will receive this treatment to see how many achieve a complete response (no cancer left at surgery). The goal is to find a more effective approach for this aggressive cancer type.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: 18-65 years old; 2. Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis; 3. Three negative type and invasive breast cancer confirmed by histopathology; Three negative breast cancer is defined as: * ER and PR negative (IHC nuclear staining\<10%) * Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification) 4. Clinically measurable lesions: Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening; 5. Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy: * Absolute value of neutrophil count ≥ 2.0 × 109/L * Hemoglobin ≥ 100g/L * Platelet count ≥ 100 × 109/L * Total bilirubin\<1.5 ULN (upper limit of normal) * Creatinine\<1.5 × ULN * AST/ALT \< 1.5×ULN; * Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If there are abnormalities, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy); 6. Cardiac ultrasound EF value ≥ 55%; 7. Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization; 8. ECOG score ≤ 1 point; 9. Voluntary signing of informed consent Exclusion Criteria: 1. There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging inspection method); 2. Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease; 3. The patient has a second primary malignant tumor, in addition to: fully treated skin cancer; 4. Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy; 5. Diagnosed with immunodeficiency or autoimmune diseases; 6. Severe lung or heart disease; 7. Hepatitis B and C are in active phase; 8. History of organ transplantation or bone marrow transplantation; 9. Pregnant or lactating women; 10. Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy; 11. Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month; 12. Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan cancer hospital
RECRUITINGZhengzhou, Henan, China
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Other studies related to the condition(s) this trial covers.
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- Off-the-Shelf immune cells target solid tumors