Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

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

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.

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Docetaxel +doxorubicin+ cyclophosphamide; Drug: Docetaxel +Cisplatin

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 Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.; Other Names: TAC regimen group
Experimental: 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.	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.; Other Names: TP regimen group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pathological complete remission rate (pCR rate)	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.	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Breast -conserving rate	Breast -conserving rate	up to 24 weeks
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)
Clinical response rate (CRR)	CRR judged based on RECIST v1.1	before breast cancer surgery

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Study Director: Zhenzhen Liu, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Actual): November 26, 2022
• Study Completion (Actual): November 26, 2022

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Doxorubicin
• Other Study ID Numbers: HELEN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No