Camrelizumab Seems Promising As New Triple-Negative Breast Cancer Treatment
People who received camrelizumab plus chemotherapy before surgery for early-stage triple-negative breast cancer had better outcomes than people who received only chemotherapy.
One way doctors judge how well treatments given before surgery (neoadjuvant treatments) work is to look at the tissue removed during surgery to see if any actively growing cancer cells are present. If no active cancer cells are present, doctors call it a pathologic complete response rate (pCR).
The study was published in JAMA.
Key takeaways
Camrelizumab is a type of immunotherapy medicine called a PD-L1 inhibitor. In the United States, camrelizumab can be used to treat liver cancer, but is not approved to treat breast cancer.
More women who received camrelizumab plus chemotherapy before surgery had a pCR than women who received chemotherapy alone, without camrelizumab. Still, follow-up was only about two years.
Camrelizumab improved pCR rates among different subtypes of triple-negative breast cancer, including cancers that had spread to the lymph nodes (node-positive) and cancers with a high risk of the cancer coming back recurrence).
Nearly all of the women who received camrelizumab and chemotherapy had an immune system-related side effect.
What the results mean for you
The researchers said that while the results are promising, longer follow-up is needed to confirm the benefits of camrelizumab.
Why do the study?
Between 40% and 80% of triple-negative breast cancers are PD-L1-positive.
PD-1 is a type of protein found on T cells, a type of immune system cell. PD-L1 is another protein found on many healthy cells. When PD-1 binds to PD-L1, it stops T cells from killing a cell. When cancer cells have a lot of PD-L1 on their surface they’re called PD-L1-positive. The extra PD-L1 stops T cells from killing these cancer cells. Camrelizumab stops PD-1 from binding to PD-L1 and allows T cells to attack the cancer cells.
Keytruda, another immune checkpoint inhibitor, is approved to be given with chemotherapy before surgery to treat early-stage triple-negative breast cancer with a high risk of recurrence. Researchers continue to look for newer, more effective immunotherapy medicines that can treat triple-negative disease.
About the study
Called CamRelief, the study was conducted at 40 hospitals in China and included 441 women aged 18 to 75 diagnosed with stage II or stage III triple-negative breast cancer. The women joined the study from November 2020 to May 2023.
The women were randomly assigned to one of two treatment regimens before surgery:
222 women received camrelizumab plus chemotherapy
219 women received chemotherapy plus a placebo, an infusion that looked just like camrelizumab but contained no medicine
The women received either camrelizumab or placebo, along with chemotherapy, every two weeks for 24 weeks.
The chemotherapy included Abraxane (chemical name: nab-paclitaxel) and carboplatin on days one, eight, and 15 in 28-day cycles for the first 16 weeks, followed by Ellence (chemical name: epirubicin) and Cytoxan (chemical name: cyclophosphamide) every two weeks for eight weeks.
After the women completed chemotherapy with or without camrelizumab, they then had surgery. After surgery, women who were assigned to receive camrelizumab continued to receive it without chemotherapy for up to one year.
Half the women were followed for less than 14 months and half were followed for longer periods of time.
The researchers defined pCR as no invasive cancer in either the breast or the lymph nodes. If a woman withdrew from the study or didn’t have surgery, the result was considered non-pCR.
Detailed results
pCR rates were:
56.8% among women who received camrelizumab and chemotherapy
44.7% among who received chemotherapy alone
Adding camrelizumab to chemotherapy improved pCR rates among the specific subgroups in the study, including node-positive cancers, stage III cancers, and both PD-L1-positive cancers and PD-L1-negative cancers.
Nearly all the women in each treatment group had side effects of any severity.
Grade 3 (severe) or higher side effects were reported by 89.2% of women receiving camrelizumab and chemotherapy and 83.1% of women receiving chemotherapy alone. Overall, side effects led 18.5% of women receiving camrelizumab and chemotherapy and 5.9% of women receiving chemotherapy alone to stop treatment.
The most common side effects in either group were low white blood cell counts, anemia, and liver problems.
About 92% of the women receiving camrelizumab and chemotherapy had an immune-related side effect. The most common (88%) was capillary endothelial proliferation, which means the number of capillaries (small blood vessels in the skin) increase and form lesions on the skin, which usually bleed. Capillary endothelial proliferation is a known side effect of camrelizumab. Other immune-related side effects included an underactive (15%) and overactive (9%) thyroid gland.
About 35% of women receiving camrelizumab and chemotherapy and 23% of women receiving chemotherapy alone had a serious side effect (grade 4 or 5). Side effects were responsible for the deaths of two women receiving camrelizumab and chemotherapy and no women receiving chemotherapy alone.
Longer follow-up is needed to figure out if camrelizumab has advantages over Keytruda for early-stage triple-negative breast cancer.
Source
Chen L, Li H, Zhang H, et al. Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial . JAMA. 2025;333(8):673–681.
— Last updated on August 14, 2025 at 5:43 PM