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A randomized controlled phase II clinical trial comparing neoadjuvant TP (docetaxel + cisplatin) with TAC (docetaxel + adriamycin + cyclophosphamide) regimen in the treatment of operable triple negative breast cancer

A randomized controlled phase II clinical trial comparing neoadjuvant TP (docetaxel + cisplatin) with TAC (docetaxel + adriamycin + cyclophosphamide) regimen in the treatment of operable triple negative breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019501
Enrollment
Unknown
Registered
2018-11-14
Start date
2018-11-27
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

TP group:(Docetaxel + cisplatin)*6 cycles
TAC group:(docetaxel + adriamycin + cyclophosphonamide) *6 cycles

Sponsors

He'nan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. Clinical T2-T4c, or T1c with axillary LN+; 3. Three-invasive, invasive breast cancer confirmed by histopathology: Three-negative breast cancer is defined as: ER and PR negative (IHC nuclear staining =100g/L; Platelet count >=100x10^9/L; Total bilirubin = 55%; 7. Women of childbearing age were tested negative for serum pregnancy test 14 days before randomization; 8. KPS score >=80 points; 9. Informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient has evidence of metastatic breast cancer (to exclude metastatic breast cancer, thoracic and abdominal CT and bone scans should be performed at any time before diagnosis to randomization; PET/CT scans can be used as an alternative imaging test); 2. Chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been accepted for this disease; 3. The patient has a second primary malignant tumor, except adequate treatment of skin cancer; 4. Because of serious, uncontrollable other medical diseases, researchers believe that there are chemotherapy contraindications.

Design outcomes

Primary

MeasureTime frame
Pathological complete remission rate;

Secondary

MeasureTime frame
Event free survival rate (EFS);Clinical response rate;The rate of breast-conserving surgery;Safety;

Countries

China

Contacts

Public ContactZhenzhen Liu

He'nan Cancer Hospital

liuzhenzhen73@126.com+86 136 0386 2755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026