nonpCR GP: A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy

Sponsor

Fudan University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04297267

Collaborator

(none)

100

Enrollment

Location

Arm

76.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: Gemcitabine Drug: Cisplatin	Phase 2

Detailed Description

This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy. Non-pCR TNBC patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of GP regimen chemotherapy(cisplatin 75 mg/m² d1 and gemcitabine 1250 mg/m² d1,8, every 3 weeks). Our primary endpoint is disease free survival (DFS). Secondary end points include overall survival (OS), recurrence free survival (RFS), distant disease free survival (DDFS)rates and safety.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy

Actual Study Start Date :

Feb 7, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GP group Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).	Drug: Gemcitabine Gemcitabine 1250mg/m2,d1,d8,every 3 weeks Drug: Cisplatin Cisplatin 75mg/m2,d1，every 3 weeks

Arm

Intervention/Treatment

Experimental: GP group

Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).

Drug: Gemcitabine

Gemcitabine 1250mg/m2,d1,d8,every 3 weeks

Drug: Cisplatin

Cisplatin 75mg/m2,d1，every 3 weeks

Outcome Measures

Primary Outcome Measures

Disease free survival [3-year]
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

Secondary Outcome Measures

Recurrence free survival [3-year]
Recurrence free survival is calculated from surgery to the first recurrence.
Distant disease free survival [3-year]
Distant disease free survival is calculated from surgery to the first distant metastasis.
Overall survival [3-year]
Overall survival is calculated from randomization to death from any cause.
Disease free survival(5year) [5-year]
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Recurrence free survival(5year) [5-year]
Recurrence free survival(5y) is calculated from surgery to the first recurrence.
Distant disease free survival(5year) [5-year]
Distant disease free survival is calculated from surgery to the first distant metastasis.
Overall survival(5year) [5-year]
Overall survival is calculated from randomization to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 70 years old
Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type)
Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition).
After standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients.
No gross or microscopic tumor residual after resection.
Patients with clear ER/PR/Her2 receptor, and ER/PR/Her2 are all negative(Specific definition: immunohistochemical detection of ER < 1% positive tumor cell is defined as the ER negative, PR < 1% positive tumor cells is defined as the PR negative, Her2 0-1 or Her2 2 + but after FISH or CISH tested negatie for c (no amplification) is defined as the Her2-negative).
No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M0.
Patients without peripheral neuropathy or I peripheral neurotoxicity.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
Patients recovered well after surgery, at least 1 weeks after the operation.
Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL.
Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
Adequate renal function: Serum creatinine ≤ 1.5ULN.
Contraception during the treatment of child-bearing women.
Adequate cardiac function :Left ventricular ejection fraction (LVEF) > 50%.
Patients must be informed of the investigational nature of this study and give written informed consent.
Patients without serious heart, lung, liver, kidney and other important organs disease history.
Patients have good compliance.

Exclusion Criteria:

Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS).
Metastasis of any part except axillary lymph nodes.
Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy.
There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer.
Patients have been enrolled in other clinical trials.
Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study.
Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension >160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization.
Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.)
Child-bearing women who are unwilling to take effective contraceptive measures in the course of research.
Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial).
Persons without personal freedom and independent civil capacity.