By Ana Espino | Published on October 29, 2025 | 2 min read
Triple-negative breast cancer (TNBC) is one of the most aggressive
subtypes of breast cancer, often affecting younger women. It is characterized
by the absence of hormone receptors and HER2 overexpression, as well as a
strong propensity for early metastatic relapse—especially within the first few
years after diagnosis. Because it is unresponsive to conventional targeted
therapies, patients with TNBC are left with limited effective treatment
options.
Given its aggressiveness and lack of specific molecular targets, new
therapeutic strategies are essential to improve prognosis. Immunotherapy
has opened new perspectives, yet trials with anti-PD-1 or anti-PD-L1
antibodies as monotherapy have shown disappointing results,
particularly in advanced disease. Meanwhile, angiogenesis, which is
frequently activated in TNBC, may act synergistically with immune modulation,
potentially enhancing antitumor responses.
In this context, this study aimed to
evaluate the efficacy and safety of combining camrelizumab
(anti-PD-1) with apatinib (anti-VEGFR2) in patients with locally
advanced or metastatic TNBC who had experienced chemotherapy failure.
A synergy that changes the game?
A total of 40 patients with locally advanced or metastatic
TNBC, previously treated with no more than two lines of chemotherapy,
were enrolled. Patients received camrelizumab 200 mg intravenously every 3 weeks
combined with apatinib 250 mg orally, administered continuously.
The primary endpoint was the objective
response rate (ORR), while secondary endpoints included duration
of response, progression-free survival (PFS), overall survival
(OS), safety, and exploratory biomarker analyses to identify
predictors of immunologic response.
The
ORR reached
43.3%, including
2 complete responses and
15
partial responses. The
median duration of response was
8.3 months, with a median
PFS of
5.6 months and a median
OS of
13.6 months. The
combination was generally
well tolerated. The most common adverse
events were
hypertension (40%),
proteinuria (32.5%), and
fatigue
(30%). Grade
≥3 adverse events occurred in 20% of patients, with no treatment-related
deaths.
Exploratory biomarker analysis
suggested that patients with high intratumoral infiltration of CD8+ T cells
derived greater benefit from treatment, indicating a synergistic effect in
tumors with pre-existing immune activation.
Toward a new weapon in the TNBC
arsenal
TNBC is characterized by clinical
aggressiveness and a lack of durable therapeutic targets. Current options
remain limited, and early relapse rates highlight an urgent need for
innovation. Among emerging strategies, combining immunotherapy with
antiangiogenic agents may represent a powerful approach to amplify
antitumor responses.
This exploratory phase II study
evaluated camrelizumab (anti-PD-1) and apatinib (anti-VEGFR2) in
pretreated patients with advanced TNBC. The findings show a promising
response rate, prolonged survival outcomes, and an acceptable
safety profile, supporting the potential of this dual-target strategy
as a second-line option.
However, important limitations
remain: the sample size was small, and the study was non-randomized.
Larger, randomized, stratified clinical trials are required to confirm
these results and determine the exact role of this combination in the
therapeutic landscape of TNBC, particularly according to tumor immune
profiles.
Read next: FOXC1: The GPS for Capecitabine in TNBC?
About the author – Ana EspinoPhD in Immunology, specialized in Virology
