TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

NCT02641847 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 1506147-4
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature and validation the efficacy of the signature.

Conditions

Triple Negative Breast Cancer; Breast Cancer

Keywords

triple negative breast cancer; mRNA-lncRNA signature; chemotherapy; high risk

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  three years

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  three years

• Recurrence free survival

  three years

• Overall survival

  three years

Study Arms (3)

High risk group A

EXPERIMENTAL

TA(E)C x 4 cycles to GP x 4 cycles (docetaxel + doxorubicin (epirubicin) + cyclophosphamide to gemcitabine + cisplatin), docetaxel: 75 mg/m2 IV on day 1; doxorubicin: 50 mg/m2 IV on day 1 or epirubicin 75 mg/m2 IV on day 1; cyclophosphamide: 500 mg/m2 IV on day 1; gemcitabine: 1250 mg/m2 IV on day 1 and 8; cisplatin: 75 mg/m2 IV on day 1, dosing interval is 21 days.

Drug: docetaxel; Drug: doxorubicin or epirubicin; Drug: cyclophosphamide; Drug: gemcitabine; Drug: cisplatin

High risk group B

ACTIVE COMPARATOR

A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days.

Drug: docetaxel; Drug: doxorubicin or epirubicin; Drug: cyclophosphamide

Low risk group C

OTHER

A(E)C x 4 cycles to T x 4 cycles (doxorubicin (epirubicin) + cyclophosphamide to docetaxel), doxorubicin: 60 mg/m2 IV on day 1 or epirubicin 90 mg/m2 IV on day 1; cyclophosphamide: 600 mg/m2 IV on day 1; docetaxel: 100 mg/m2 IV on day 1, dosing interval is 21 days.

Drug: docetaxel; Drug: doxorubicin or epirubicin; Drug: cyclophosphamide

Interventions

docetaxel DRUG

High risk group A; High risk group B; Low risk group C

doxorubicin or epirubicin DRUG

High risk group A; High risk group B; Low risk group C

cyclophosphamide DRUG

High risk group A; High risk group B; Low risk group C

gemcitabine DRUG

High risk group A

cisplatin DRUG

High risk group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old
• Expected survival \> 12 months
• Baseline Eastern Cooperative Oncology Group Performance Status rating 0-1
• Naïve to chemotherapy or hormonal treatments
• Pathology confirmed invasive ductal carcinoma of breast
• Triple negative breast cancer confirmed by pathology
• No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)
• No advanced metastasis or metastasis involving brain or liver
• Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L
• Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60 Unit/L, serum total bilirubin ≤ 2.5 times Upper Limit of Normal, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L
• No coagulation abnormality
• Normal heart function, with normal ECG and left ventricular ejection fraction ≥ 55%
• Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration
• No coagulation abnormality
• Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.

You may not qualify if:

• Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
• Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
• Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment
• Peripheral neuropathy \>1 degree caused by any reason
• History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg);
• Breast cancer during lactation or pregnancy
• Mental illness or incompliance to treatment caused by other reasons
• Known history of severe hypersusceptibility to any agents used in the treatment protocol
• Patients received major surgery or suffered from severe trauma within 2 months of first administration
• Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial
• Known to be infected with human immunodeficiency virus (HIV)
• Other circumstances considered to be inappropriate to be enrolled by researchers

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• He M, Jiang YZ, Gong Y, Fan L, Liu XY, Liu Y, Tang LC, Mo M, Hou YF, Di GH, Liu GY, Yu KD, Wu J, Yan X, Zeng XH, Fu DY, Song CG, Zhuang ZG, Wu KJ, Wang J, Wang ZH, Shao ZM. Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial. BMJ. 2024 Oct 23;387:e079603. doi: 10.1136/bmj-2024-079603.

  PMID: 39442958 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Docetaxel; Doxorubicin; Epirubicin; Cyclophosphamide; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 25, 2024

Record last verified: 2023-09

Locations

CN (1)