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

NCT05302336 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide

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).

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302336 on ClinicalTrials.gov