Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

Phase 2

Completed

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Docetaxel +Cisplatin; Drug: Docetaxel +doxorubicin+ cyclophosphamide

• Registration Number: NCT04664972
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.

Detailed Description

In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6\*TP (docetaxel + cisplatin) regimen and traditional 6\*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.

Study Timeline

• Study Start: 2018-11-23
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

1. Age: 18-70.

2. Clinical T2-T4c, or T1c with axillary LN+.

3. triple negative and invasive breast cancer confirmed by histopathology:

   Triple negative breast cancer is defined as:

   • negative for ER and PR (IHC nuclear staining < 10%).
   • Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and FISH without amplification).

4. Clinically evaluable lesions: The presence of lesions that could be evaluated by ultrasound, molybdenum target or magnetic resonance imaging (optional) was within 1 month before randomization.

5. The function examination of organs/bone marrow showed no contraindication within 1 month before chemotherapy.

   • The absolute value of neutrophil count ≥2.0 × 109 / L.
   • The value of hemoglobin ≥100g/L.
   • Platelet count ≥100 × 109/L.
   • Total bilirubin < 1.5 ULN (normal value online).
   • Creatinine < 1.5 × ULN.
   • AST/ALT < 1.5 × ULN.

6. The EF value of echocardiography≥55%.

7. The serum pregnancy test was negative for fertile woman within 14 days before randomization..

8. KPS score≥80.

9. Informed consent.

Exclusion Criteria

1. Metastatic breast cancer.
2. Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.
3. The patient had dual primary malignancies, except for skin cancer, which was treated.
4. Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP regimen group	Docetaxel +Cisplatin	The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
TAC regimen group	Docetaxel +doxorubicin+ cyclophosphamide	The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.

Primary Outcome Measures

Name	Time	Method
The pathological complete remission rate (pCR rate)	Immediately after surgery	Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery.

Secondary Outcome Measures

Name	Time	Method
Event free survival rate (EFS)	5 years after surgery	Time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or remote recurrence, second primary malignant tumor (breast cancer or other cancers) or death from any cause.
Clinical response rate (CRR)	before breast cancer surgery	CRR judged based on RECIST v1.1
Breast -conserving rate	up to 24 weeks	Breast -conserving rate
Number of adverse events and serious adverse events	After each cycle of chemotherapy (21 days as 1 cycle)	Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China