NCT05302336

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

Status unknown Phase 4 Last updated 14 April 2022

What this trial tests

Phase 4 trial testing Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide in Breast Cancer in 402 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
30 December 2024

30 December 2024

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	402
Start date	1 May 2022
Primary completion	30 December 2024
Estimated completion	30 December 2024
Sites	1 location across China

Drugs / interventions tested

• Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Chemotherapeutic Toxicity — all drugs for Chemotherapeutic Toxicity →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 70, female only, with Breast Cancer or Chemotherapeutic Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
   Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234