Shanghai medical experts have discovered a new treatment method that significantly improved outcomes for patients with the most aggressive subtype of breast cancer during a clinical trial.

The method was uncovered during a two-year trial named "FUTURE-SUPER", which involved 139 patients. It extends progression-free survival for patients suffering from metastatic triple-negative breast cancer, a subtype of the disease that has the worst prognosis due to its high aggressiveness, early recurrence and metastasis, and a lack of effective treatment targets.

Triple-negative breast cancer accounts for approximately 15 percent of all breast cancer cases, and the traditional one-size-fits-all chemotherapy remains the standard treatment, experts said.

The trial used a "subtyping-based precision treatment" approach, combining chemotherapy with targeted therapy or immunotherapy. The use of the method resulted in a substantial extension in progression-free survival for such patients compared with the standard treatment. Researchers from the Fudan University Shanghai Cancer Center believe the novel approach can address limitations of the current standard treatment, which lacks individualization and has unsatisfactory efficacy.

A paper detailing the findings of the research, a joint effort between the Department of Breast Surgery at the cancer center and Jiangsu Hengrui Pharmaceuticals Co, was published in the journal The Lancet Oncology on Jan 9.

Professors Shao Zhiming, Wang Zhonghua, Jiang Yizhou and Fan Lei led the research.

In the clinical study, patients with either metastatic triple-negative breast cancer or diseases not appropriate for surgery were enrolled.

They were divided into five treatment groups based on molecular subtypes. They were randomly assigned to receive traditional chemotherapy (the control group) or chemotherapy combined with a molecular targeted anti-tumor drug or an anti-PD-1 antibody (the subtyping-based precision treatment group).

During the median follow-up period of 22.5 months, the median progression-free survival period of patients in the precision treatment group was 11.3 months, about 5.5 months longer than that of patients in the conventional chemotherapy group.

Notably, a subset of patients categorized as immunomodulatory showed the most significant increase in progression-free survival, with a median of 15.1 months — 8.6 months longer than traditional chemotherapy.

This currently represents the most substantial survival benefit worldwide. "Such results represent a breakthrough in addressing the limitations of targeted therapies for treating this subtype of breast cancer," Fan said.

She also highlighted the precision treatment group's remarkable response rate of 80 percent, significantly higher than the 44.8 percent in the traditional chemotherapy group, with no serious adverse effects reported.

Fan shared the story of a 36-year-old patient who participated in the trial in April 2021.

The woman underwent a modified radical mastectomy on her right breast in October 2019, and was diagnosed with stage II triple-negative breast cancer. She completed standard adjuvant chemotherapy, which ended in March 2020. However, in April 2021, metastases were found in both lungs and lymph nodes.

After receiving the precision treatment in the trial, the tumors experienced complete regression for more than 33 months, enabling her to return to a normal life and work routine.

"The hospital is seeking to launch clinical trials at multiple centers using the precision treatment regimen, with the ultimate aim of advancing breast cancer treatment to the highest standard nationwide," said Jiang, who is also vice-president of the cancer center.

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