Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05302336
Status:
RECRUITING
Last Update Posted:
2022-04-14
First Post:
2022-03-20
Brief Title:
AC vs TC in Patients With HR-positive HER2-negative Early Breast Cancer
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
A Randomized Controlled Study of AC Doxorubicin Hydrochloride LiposomeCyclophosphamide vs TC DocetaxelCyclophosphamide Regimens for Postoperative Adjuvant Chemotherapy in Patients With HR-positive HER2-negative Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie choice of chemotherapy regimen and hormone receptor HR estrogen receptor andor 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 13 of the patients were ER negative and the HER-2 status of the patients was not limited 9735 Half of the trials enrolled population had axillary lymph node metastases From a large number of clinical studies it has been found that the patients 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
Detailed Description:
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 doxorubicincyclophosphamide 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None