Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

Triple Negative Breast Cancer Clinical Trial

Official title:

Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664972
• Other study ID #: HELEN-001
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2018
• Est. completion date: November 26, 2022

Study information

• Verified date: April 2024
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathological complete remission rate (pCR rate)	It means that there is no invasive cancer (i.e. ypT0/is, ypN0) in the resected specimens (breast + armpit) after operation	Immediately after surgery
Secondary	Event free survival rate (EFS)	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.	5 years after surgery
Secondary	Objective response rate	Determine objective response rate based on RECIST v1.1	before breast cancer surgery
Secondary	Breast -conserving rate	Breast -conserving rate	up to 24 weeks
Secondary	Number of adverse events and serious adverse events	Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0	After each cycle of chemotherapy (21 days as 1 cycle)