Shanghai medical experts have developed an innovative neoadjuvant treatment approach for triple-negative breast cancer, one of the most aggressive forms of the disease, significantly increasing the rate of tumor disappearance before surgery from 44.7 percent to 56.8 percent.
The research, led by Fudan University Shanghai Cancer Center, combines traditional chemotherapy with Camrelizumab, a novel Chinese-developed immunotherapy drug. The treatment helps shrink tumors and extends patient survival, researchers said Tuesday.
The phase III clinical trial involved 441 patients from 40 hospitals across China and was the first one on an original breast cancer medicine based on data from the Chinese population to be published in the prestigious Journal of the American Medical Association.
Triple-negative breast cancer accounts for 10 percent to 20 percent of all breast cancer cases and is particularly difficult to treat. The cancer often recurs quickly and spreads aggressively, leading to poor survival outcomes.
Neoadjuvant chemotherapy, which involves shrinking tumors with drugs before surgery, is a standard treatment for this cancer. However, international efforts to enhance outcomes by integrating immunotherapy have mainly focused on Western populations and excluded patients with extensive lymph node metastases.
The new research, named "Cam-Relief," is one of the first largescale studies to examine immunotherapy's benefits for high-risk patients in China.
"Camrelizumab is a high-efficiency PD-1 immune checkpoint inhibitor developed by Jiangsu Hengrui Pharmaceuticals Co," said Shao Zhimin, director of general surgery and breast surgery department at the Shanghai Cancer Center. Immune checkpoint inhibitors help the body's immune system detect and attack cancer cells more effectively.
The study began in 2020, enrolling patients with early or locally advanced triple-negative breast cancer. Participants were given either Camrelizumab or a placebo alongside chemotherapy before surgery. After surgery, treatment continued with either the drug or placebo for up to a year.
After a median follow-up of 14.4 months, the study found that the Camrelizumab group achieved a pathological complete response or PCR rate of 56.8 percent, compared to 44.7 percent in the placebo group. PCR refers to the complete disappearance of invasive cancer in the breast and nearby lymph nodes after treatment, a key indicator of better long-term outcomes.
"Patients achieving PCR have significantly lower risks of recurrence and better disease-free survival," Shao said.
Subgroup analysis showed that the treatment was effective for a range of patients, regardless of age, physical condition, or disease stage.
The findings were also highlighted at the San Antonio Breast Cancer Symposium, the world's largest conference on breast cancer, last week.
A 41-year-old participant surnamed Chen, described the treatment as "magical" and "unexpected". After surgery, she continued using Camrelizumab without chemotherapy, experiencing minimal side effects.
"Compared to chemotherapy, which had so many adverse effects, this was much easier to handle," Chen said.
The research offers hope for improving outcomes in one of the most challenging cancer types. "Such research outcomes are quite exciting, offering the potential to truly transform clinical practice in neoadjuvant treatment," Shao said.
