Triple Negative Breast CancerNCT04067102
Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC
A study testing Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide and paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in people with Triple Negative Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer. 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?
- Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide and paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to May 2026
- Phase
- Interventional
- 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
- Female, aged ≥ 18 yrs and ≤70 yrs；
- Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
- The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
- ECOG performance status 0-1；
- LVEF≥55%；
- Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
- Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
- The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.
Who cannot join
- Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
- New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
- Patients with severe systemic infections or other serious illnesses；
- Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
- Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
- Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
- Participated in other experimental studies within 30 days before the first dose of study drug administration
- Researchers judged patients who were unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
About this study
Official title: Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)
To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide, paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide
- 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.
Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamideDrug
Paclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment
paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamideDrug
Paclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel Based Regimens | Experimental | Not described Receives: Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide |
| Paclitaxel Based Regimens | Active comparator | Not described Receives: Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response（pCR）
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)
Measured: 6 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Measured: 3 months
Disease-free survival（DFS）
Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.
Measured: 5 years
Overall survival（OS）
Overall survival is defined as the length of time from random assignment to death or to last contact.
Measured: 5 years
adverse events（AEs）
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
Measured: until 28 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start10 May 2019
- Primary completionMay 2021 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yunjiang, Hebei Medical University Fourth Hospital
- Investigators
- Yunjiang Liu, MD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067102
- Sponsor's protocol ID
- TNBC-NEO
- Status last verified
- Jul 2021
- First submitted
- 14 Aug 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT04067102
- Acronym / sponsor ID
- TNBC-NEO
- Conditions
- Triple Negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel Based Regimens | Experimental | Drug: Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide |
| Paclitaxel Based Regimens | Active comparator | Drug: paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, aged ≥ 18 yrs and ≤70 yrs；
- Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
- The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
- ECOG performance status 0-1；
- LVEF≥55%；
Key exclusion criteria (8 listed)
- Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
- New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
- Patients with severe systemic infections or other serious illnesses；
- Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
- Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamidePaclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment | Drug | Nab-paclitaxel Based Regimens |
| paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamidePaclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher | Drug | Paclitaxel Based Regimens |
Primary outcome
pathologic complete response（pCR）
Time frame: 6 months
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 3 months
Disease-free survival（DFS）
Time frame: 5 years
Overall survival（OS）
Time frame: 5 years
adverse events（AEs）
Time frame: until 28 days after the last study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunjiang Liu, MD principal investigator
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide and paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in people with Triple Negative Breast Cancer, run by Hebei Medical University Fourth Hospital 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Jul 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
pathologic complete response（pCR） (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2021.