Breast CancerPhase 4NCT05302336
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
A Phase 4 study testing Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide in people with Breast Cancer and Chemotherapeutic Toxicity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapeutic Toxicity
- What is being tested?
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejing, 310000
Lifeng Dong, MD and P.hD, +86 13567161282, lifengdong@zju.edu.cn
Yingkuan Shao, MD and P.hD, +86 13777896681, ykshao@zju.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Chemotherapeutic Toxicity
- Being tested
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + CyclophosphamideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Liposomal doxorubicin + Cyclophosphamide | Active comparator | 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 Receives: Drug: Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide |
| Docetaxel + Cyclophosphamide | Active comparator | 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 Receives: Drug: Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302336
- Sponsor's protocol ID
- 2021-1122
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05302336
- Acronym / sponsor ID
- 2021-1122
- Conditions
- Breast Cancer, Chemotherapeutic Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal doxorubicin + Cyclophosphamide | Active comparator | Drug: Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + CyclophosphamideLiposomal 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 | Active comparator | Drug: Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + CyclophosphamideDocetaxel + 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + CyclophosphamideAll 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). | Drug | Docetaxel + Cyclophosphamide, Liposomal doxorubicin + Cyclophosphamide |
Primary outcome
disease-free survival
Time frame: 5 years
the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
1 secondary outcome
side effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide in people with Breast Cancer and Chemotherapeutic Toxicity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lifeng Dong, MD and P.hD (+8613567161282, lifengdong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.