AzTrials
AzTrials

Triple Negative Breast CancerPhase 2nonpCR GPNCT04297267

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

A Phase 2 study testing Gemcitabine and Cisplatin in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
7 Feb 2017to 30 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital/ Institute, Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Gemcitabine, Cisplatin
Keywords
gemcitabine, cisplatin, non-pCR, TNBC
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • CisplatinDrug

    Cisplatin 75mg/m2,d1，every 3 weeks

Study groups in NCT04297267
Study groupRoleWhat they receive
GP groupExperimentalPatients 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).
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

    Measured: 3-year

Secondary outcomes (7)

  1. Recurrence free survival

    Recurrence free survival is calculated from surgery to the first recurrence.

    Measured: 3-year

  2. Distant disease free survival

    Distant disease free survival is calculated from surgery to the first distant metastasis.

    Measured: 3-year

  3. Overall survival

    Overall survival is calculated from randomization to death from any cause.

    Measured: 3-year

  4. Disease free survival(5year)

    The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

    Measured: 5-year

  5. Recurrence free survival(5year)

    Recurrence free survival(5y) is calculated from surgery to the first recurrence.

    Measured: 5-year

  6. Distant disease free survival(5year)

    Distant disease free survival is calculated from surgery to the first distant metastasis.

    Measured: 5-year

  7. Overall survival(5year)

    Overall survival is calculated from randomization to death from any cause.

    Measured: 5-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start7 Feb 2017
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297267
Sponsor's protocol ID
1608162-19-1805B
Acronym
nonpCR GP
Status last verified
Jul 2022
First submitted
4 Mar 2020
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Cisplatin in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in