Clinical trial NCT04664972: Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-11
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The pathological complete remission rate (pCR rate)
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Event free survival rate (EFS)
timeFrame: 5 years after surgery
measure: Clinical response rate (CRR)
timeFrame: before breast cancer surgery
measure: Breast -conserving rate
timeFrame: up to 24 weeks
measure: Number of adverse events and serious adverse events
timeFrame: After each cycle of chemotherapy (21 days as 1 cycle)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zhenzhen Liu
role: STUDY_DIRECTOR
References: