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Liposomal doxorubicin + cyclophosphamide A 35mg(per r square meter of body surface)+C 600mg(per r square meter of body surface) every 3 weeks for 4 cycles

Docetaxel + Cyclophosphamide T 75mg(per r square meter of body surface)+C 600mg(per r square meter of body surface) every 3 weeks for 4 cycles

All patients who meet the inclusion criteria must first sign the "Informed Consent" after learning about the details of the trial, and they can be formally enrolled only when they have completed all the pre-enrollment examinations and are qualified. Recruitment will continue until the planned number of cases is completed. The trial was not terminated until each surviving patient was followed for at least 60 months after treatment ended or when all patients had died. The randomization table was generated by the SAS software program, and the patients were randomly divided into the experimental group (AC liposomal doxorubicin + cyclophosphamide) and the control group (docetaxel + cyclophosphamide).

Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide

Lifeng Dong, MD and P.hD

Yingkuan Shao, MD and P.hD

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.

AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer

A Randomized Controlled Study of AC (Doxorubicin Hydrochloride Liposome/Cyclophosphamide) vs TC (Docetaxel/Cyclophosphamide) Regimens for Postoperative Adjuvant Chemotherapy in Patients With HR-positive, HER2-negative Early Breast Cancer

the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

hair loss: Sinclair scale for the female pattern was used to evaluate hair loss. Stage 1 is normal. Stage 2 shows the widening of the central part. Stage 3 shows a widening of the central part and loss of volume lateral to the part line. Stage 4 shows the development of a bald spot anteriorly. Stage 5 shows advanced hair loss. Hair loss was assessed after the second and fourth chemotherapy treatments.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer	NCT05302336	Breast Cancer Chemotherapeuti...	Liposomal doxor...	18 Years - 70 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer	NCT05302336	Breast Cancer Chemotherapeuti...	Liposomal doxor...	18 Years - 70 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

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