Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

NCT ID: NCT04664972

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-23
• Study Completion Date: 2022-11-26

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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAC regimen group

The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.

Group Type: PLACEBO_COMPARATOR

Docetaxel +doxorubicin+ cyclophosphamide

Intervention Type: DRUG

The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.

TP regimen group

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.

Group Type: EXPERIMENTAL

Docetaxel +Cisplatin

Intervention Type: DRUG

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.

Interventions

Docetaxel +doxorubicin+ cyclophosphamide

The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

TAC regimen group; TP regimen group

Eligibility Criteria

Inclusion Criteria

1. Age: 18-70.

2. Clinical stage Ⅱ-Ⅲ.

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 without FISH amplification).

4. With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.

5. Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:

• neutrophils count absolute value ≥ 2.0×109/L
• hemoglobin ≥ 100g/L
• blood platelet ≥ 100×109/L
• total bilirubin < 1.5 ULN (upline of normal value)
• creatinine < 1.5×ULN
• AST/ALT < 1.5×ULN;

6. Cardiac ultrasound EF value ≥ 55%.

7. Females of childbearing age with negative serum pregnancy test 14 days before randomization.

8. ECOG score ≤1.

9. Sign informed consent.

Exclusion Criteria

1. Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .

2. The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.

3. The patient has a second primary malignant tumor, except for:

• Thoroughly treated skin cancer

4. Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhenzhen Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenzhen Liu

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HELEN-001

Identifier Type: -

Identifier Source: org_study_id