Back to results

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

Primary Purpose

Breast Cancer, Chemotherapeutic Toxicity

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

Received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason;
New York Heart Association (NYHA) score identifies patients with heart disease of grade II or above (including grade II);
Patients with severe systemic infection or other serious diseases;
Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
Other malignant tumors have occurred in the past 5 years, except for skin cancer of cured cervical carcinoma in situ and non-melanoma;
Patients of childbearing age who are pregnant or breastfeeding and who refuse to take appropriate contraceptive measures during this trial;
Participated in other experimental studies within 30 days before the administration of the first dose of the investigational drug;
Patients judged by the investigator to be inappropriate to participate in this study.

Sites / Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Liposomal doxorubicin + Cyclophosphamide

Docetaxel + Cyclophosphamide

Arm Description

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

Outcomes

Primary Outcome Measures

disease-free survival

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

Secondary Outcome Measures

side effect

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.

Full Information

NCT ID

NCT05302336

First Posted

March 20, 2022

Last Updated

April 7, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05302336

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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, 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Chemotherapeutic Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Liposomal doxorubicin + Cyclophosphamide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Docetaxel + Cyclophosphamide

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide

Intervention Description

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).

Primary Outcome Measure Information:

Title

disease-free survival

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

side effect

Description

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; New York Heart Association (NYHA) score identifies patients with heart disease of grade II or above (including grade II); Patients with severe systemic infection or other serious diseases; Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients; Other malignant tumors have occurred in the past 5 years, except for skin cancer of cured cervical carcinoma in situ and non-melanoma; Patients of childbearing age who are pregnant or breastfeeding and who refuse to take appropriate contraceptive measures during this trial; Participated in other experimental studies within 30 days before the administration of the first dose of the investigational drug; Patients judged by the investigator to be inappropriate to participate in this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lifeng Dong, MD and P.hD

Phone

+8613567161282

lifengdong@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yingkuan Shao, MD and P.hD

Phone

+8613777896681

ykshao@zju.edu.cn

Facility Information:

Facility Name

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

City

Hanzhou

State/Province

Zhejing

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lifeng Dong, MD and P.hD

Phone

+86 13567161282

lifengdong@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Yingkuan Shao, MD and P.hD

Phone

+86 13777896681

ykshao@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs