AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer (NCT05302336) | Clinical Trial Compass
UnknownPhase 4
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
China402 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Age: 18\~70 years old, female;
✓. Patients with primary breast cancer diagnosed by histopathology and clinical stage of T1b-2 N0;
✓. The expression of HER-2 is negative by immunohistochemistry (IHC). If the expression of HER-2 is 2+, in situ hybridization is required to confirm that the HER-2 gene is not amplified; HR+.
✓. ECOG physical fitness score 0-1 points;
✓. LVEF≥55%;
✓. Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
✓. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ;
✓. The patient has good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.
Exclusion criteria
What they're measuring
1
disease-free survival
Timeframe: 5 years
Trial details
NCT IDNCT05302336
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University