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Hormone Receptor Positive HER-2 Negative Breast CancerPhase 3NCT05901428

TCb vs EC-T in High Risk ER+/HER2- Breast Cancer

A Phase 3 study testing Docetaxel, Carboplatin and Epirubicin in people with Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Docetaxel, Carboplatin and Epirubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,736 participants
Where
1 siteChina
Study dates
1 Jun 2023to Jun 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Women aged 18-70
  • Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)
  • The initial diagnosis condition can be directly operated, without absolute surgical contraindications
  • No gross or microscopic tumor remains after surgical resection
  • Adjuvant chemotherapy should be started within eight weeks after surgery
  • Patients with Hormone receptor-positive, HER2-negative (HR+HER2-), and positive axillary lymph nodes ≥4
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  • Definition of ER and Progesterone Receptor (PgR) positive: Positive ER for tumor cells detected by immunohistochemistry is defined as ER positive , and positive PgR for tumor cells detected as PgR positive .
  • There was no evidence of metastasis in clinical or imaging aspects during preoperative examination
  • No peripheral neuropathy;
  • Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
  • Good postoperative recovery, at least 1 week interval between surgery
  • Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no granulocyte colony stimulating factor (G-CSF) support therapy within 2 weeks prior to day 1 of course 1); Lymphocyte count≥ 500 cells/μL; Platelet count≥ 100,000 cells/μL (no platelet transfusion within 2 weeks before day 1 of course 1; hemoglobin≥ 9.0 g/dL; Aspartate transferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase≤ 2.5 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients not receiving anticoagulant therapy: INR or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days before the start of study therapy and a stable International normalised ratio (INR); creatinine clearance≥ 30 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 2.5 g/dL
  • For women of childbearing age: agree to remain abstinent (avoid heterosexual intercourse) or take an annual failure rate for at least 5 months during treatment and at least 6 months after the last dose of docetaxel or epirubicin, or 12 months after the last dose of cyclophosphamide, whichever occurs last < 1% of contraception. A woman who is postmenopausal but has not yet reached postmenopausal status (menopause lasts ≥for 12 consecutive months, for no reason other than menopause) and has not undergone sterilization (ovarian and/or hysterectomy) is considered fertile.
  • Cardiac function: left ventricular ejection fraction (LVEF) >50% by ultrasound examination
  • Sign the Informed Consent Form (ICF)

Who cannot join

  • Have a history of invasive cancer
  • T4 clinical tumors as specified in the Union for International Cancer Control/American Joint Committee on Cancer tumor (UICC/AJCC) Tumor-Lymph Node Metastasis Classification (8th Edition), including inflammatory breast cancer
  • For currently diagnosed breast cancer, prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer radiotherapy (RT), except for treatments planned under this study condition
  • Previous treatment with anthracyclines or taxane for any malignant tumor
  • History of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS), treatment of ipsilateral breast cancer with systemic therapy, hormone therapy, or RT, followed by invasive cancer, patients treated with DCIS/LCIS only surgery and/or RT for contralateral DCIS may be enrolled in the study.
  • Prior to randomization, cardiopulmonary dysfunction according to any of the following: history of NCI CTCAE v4.0 ≥3 symptomatic congestive heart failure or New York College of Cardiology (NYHA) standard classification≥ II, angina requiring antianginal drugs, severe arrhythmias not treated with appropriate medical therapy, severe conduction abnormalities, or clinically significant valvular disease, high-risk, uncontrolled arrhythmias (i.e., atrial tachycardia with > resting rate). 100/min, significant ventricular arrhythmia [ventricular tachycardia], or high-grade atrioventricular (AV) block [second-degree AV block type 2, or third-degree atrioventricular block]), significant symptoms associated with left ventricular dysfunction, arrhythmia, or myocardial ischemia (grade ≥2), myocardial infarction within 12 hours prior to randomization; with uncontrolled hypertension (systolic blood pressure> 180 mmHg and/or diastolic blood pressure > 100 mmHg; ECG findings show transmural infarction; Oxygen therapy is required
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  • Prior malignancy within 5 years prior to randomization, with negligible risk of metastasis or death, except for malignancy that is expected to heal after treatment (i.e., appropriately treated carcinoma in situ or basal or squamous cell skin cancer).
  • Known allergic or hypersensitivity to any component of the docetaxel, carboplatin, cyclophosphamide, or epirubicin preparations; Allergic or hypersensitivity reactions are known to filgrastim, pegfilgrastim, or granulocyte-macrophage colony-stimulating factor (GM-CSF) preparations
  • Patients with serious infections (including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia) that occurred within 4 weeks prior to initiation of study treatment, who received therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment, and who received prophylactic antibiotic therapy (such as prophylaxis for urinary tract infection or prevention of chronic obstructive pulmonary disease) may be enrolled.
  • Pregnant or lactating women, or women planning to become pregnant during the study period.
  • Poorly controlled hypertension (defined as: systolic blood pressure > 150 mmHg and/or diastolic blood pressure >100 mmHg)
  • Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, and inability to complete the trial protocol and follow-up workers (systematic evaluation is required before trial enrollment)
  • Persons without personal freedom and independent capacity for civil conduct.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Breast cancer institute of Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

    Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com

    Lei Fan, MD, 86-21-641755901105, cmchen@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Breast Cancer

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

Keywords
LN≥4, TCb, EC-T

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer

  • CarboplatinDrug

    Carboplatin is a deoxyribonucleic acid (DNA) synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.

  • EpirubicinDrug

    Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.

  • CyclophosphamideDrug

    Cyclophosphamide is a nitrogen mustard that exerts its anti-neoplastic effects through alkylation.

Study groups in NCT05901428
Study groupRoleWhat they receive
TCb armExperimentalChemotherapy: Intensive intravenous dose of docetaxel (75 mg/m2) + intravenous (IV) carboplatin [area under the curve (AUC) =5-6] repeated administration of Q3W for a total of 6 doses
Receives: Drug: Docetaxel; Drug: Carboplatin
EC-T armActive comparatorChemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q3W for a total of 4 doses, followed by (IV) docetaxel (80 mg/m2) (Q3W) for 4 doses
Receives: Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. invasive disease-free survival (iDFS)

    invasive disease-free survival

    Measured: 5 years

Secondary outcomes (4)

  1. distant relapse free survival (DRFS)

    distant relapse free survival

    Measured: 5 years

  2. overall survival (OS)

    overall survival

    Measured: 5 years

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0

    Measured: through study completion, an average of 1 year

  4. Quality of life measured by EORTC QLQ C30

    Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start1 Jun 2023
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,736 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901428
Sponsor's protocol ID
SCHBCC-N051
Status last verified
Sep 2026
First submitted
7 May 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Carboplatin and Epirubicin in people with Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Fudan University 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 15 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

invasive disease-free survival (iDFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901428.

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 28 Sep 2026.

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