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

ConditionHormone Receptor Positive HER-2 Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel

    Drug

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

  • Carboplatin

    Drug

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

  • Epirubicin

    Drug

    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.

  • Cyclophosphamide

    Drug

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

Treatment groups

1,736 Participants
are divided into 2 treatment groups
Group A: TCb armExperimental treatment 2 interventions
Group B: EC-T armActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

invasive disease-free survival (iDFS)

invasive disease-free survival

Time frame
5 years

Secondary outcomes

1

distant relapse free survival (DRFS)

distant relapse free survival

Time frame
5 years
2

overall survival (OS)

overall survival

Time frame
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

Time frame
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.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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