AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for
perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is
based on breast cancer subtype, i.e. choice of chemotherapy regimen and hormone receptor (HR)
[estrogen receptor and/or progesterone receptor], human epidermal growth factor receptor 2
(HER2) related. Although HR-positive breast cancer has a better prognosis than other
subtypes, standard chemotherapy for HR-positive breast cancer has not been established. The
American Oncology Research Trial 9735 demonstrated that docetaxel + cyclophosphamide (TC)
produced better results than doxorubicin + cyclophosphamide (AC) in adjuvant breast cancer
treatment. However, the enrolled subjects of the 9735 trial did not strictly limit the tumor
size, and the tumor size of some patients was greater than 5 cm; the hormone status of the
patients was not limited, about 1/3 of the patients were ER negative, and the HER-2 status of
the patients was not limited; 9735 Half of the trial's enrolled population had axillary lymph
node metastases. From a large number of clinical studies, it has been found that the
patient's tumor size, ER negative, HER-2 positive, lymph node metastasis and other factors
are risk factors for breast cancer recurrence and metastasis after surgery. Therefore, for
HR-positive, HER-2-negative early breast cancer patients, whether the TC regimen is superior
to the AC regimen remains uncertain. The current CSCO breast cancer treatment still
recommends the AC regimen as one of the options for adjuvant breast cancer treatment. Other
studies have shown a benefit of anthracyclines in high-risk HR-positive disease, and TC is a
suitable option for lower risk. The TC regimen had a higher incidence of myelosuppression and
allergy than the AC regimen.
At present, the liposomal doxorubicin developed on the basis of doxorubicin has been used for
the first-line treatment of advanced breast cancer, and both NCCN and CSCO guidelines have
related recommendations. However, the application of liposomal doxorubicin in adjuvant
therapy of breast cancer still lacks sufficient evidence-based medicine. The current research
shows that doxorubicin under the encapsulation of liposomes prolongs the half-life of the
drug, reduces the cardiotoxicity, and the drug is continuously enriched in the tumor tissue
to improve the anti-tumor activity. In addition, liposomal doxorubicin has the advantage of
less hair loss during chemotherapy, which meets the needs of some clinical patients for hair
protection. There is still a lack of clinical studies on the use of AC (liposomal
doxorubicin/cyclophosphamide) with other early breast cancer adjuvant chemotherapy regimens.
This study aimed to evaluate the efficacy and safety of AC (liposomal doxorubicin +
cyclophosphamide) and TC (docetaxel + cyclophosphamide) regimens as adjuvant therapy for HR+
HER2- early breast cancer.
Phase:
Phase 4
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University