Breast CancerPhase 2NCT02628613
Neoadjuvant Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin in Breast Cancer With TEKT4 Variations
A Phase 2 study testing Vinorelbine plus Epirubicin and Paclitaxel plus Epirubicin in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to compare the efficiency and safety between paclitaxel combined with epirubicin and vinorelbine combined with epirubicin when used in neoadjuvant chemotherapy for locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variations. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vinorelbine plus Epirubicin and Paclitaxel plus Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Feb 2019
- 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: 18-70 years old
- Expected survival > 12 months
- Baseline ECOG Performance Status rating 0-1
- Naïve to chemotherapy or hormonal treatments
- Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically
- Locally advance breast cancer of stage IIb-IIIc
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- HER-2 negative confirmed by immunohistochemistry, Ki-67≥20%
- TEKT4 variation confirmed by DNA sequencing
- No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)
- Patients have measurable lesions (according to RECIST v1.1 criteria)
- Intention to cooperate with baseline puncture and neoadjuvant therapy
- No advanced metastasis or metastasis involving brain or liver
- Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L
- Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L
- No coagulation abnormality
- Normal heart function, with normal ECG and LVEF ≥ 55%
- Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration
- No coagulation abnormality
- Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.
Who cannot join
- Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
- Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
- Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment
- Peripheral neuropathy >1 degree caused by any reason
- History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg);
- Breast cancer during lactation or pregnancy
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- Unwillingly to receive baseline puncture or neoadjuvant therapy
- Mental illness or incompliance to treatment caused by other reasons
- Known history of severe hypersusceptibility to any agents used in the treatment protocol
- Patients received major surgery or suffered from severe trauma within 2 months of first administration
- Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial
- Known to be infected with human immunodeficiency virus (HIV)
- Other circumstances considered to be inappropriate to be enrolled by researchers
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Randomized Clinical Trial and Biomarker Analysis of Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin as Neoadjuvant Chemotherapy in Locally Advanced HER2-Negative Breast Cancer With TEKT4 Variations
The purpose of this study is to compare the efficiency and safety between paclitaxel combined with epirubicin and vinorelbine combined with epirubicin when used in neoadjuvant chemotherapy for locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variations.
Read the detailed description
Taxane-based chemotherapy is the cornerstone treating breast cancer, however remarkable percentage of breast cancer patients presents with primary or secondary taxane resistance. Currently no established biomarker has been reported clinically for predicting taxane sensitivity. Our previous study indicated that TEKT4 variation decreased the stability of intracellular microtubule, and TEKT4 variant cells behaves higher resistance to microtubule-stabilizing agents such as taxane, while enhanced sensibility to microtubule depolymerization agents such as vinorelbine. This study is intended to confirm that TEKT4 variation predicts the prognosis of taxane-based chemotherapy through the prospective clinical trials.
This study intends to evaluate the efficiency and safety of two neoadjuvant therapies: paclitaxel combined with epirubicin and vinorelbine combined with epirubicin, in treating locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variation.
Primary endpoint of study: pathologic Complete Response (pCR). Secondary endpoints of the study: Objective response rate (CR+PR). Exploratory endpoint: Based on pretreatment tumor and matched blood samples, the correlation between biomarker and efficiency is explored.
This open single center prospective randomized control study includes patients locally advanced (IIb-IIIc) HER2-negative patients with TEKT4 variation diagnosed with histopathology and Sanger sequencing. Patients randomized to Group A or Group B to receive respective neoadjuvant chemotherapy. Among which Group A: PE x 4 cycles (paclitaxel + epirubicin), paclitaxel: 80 mg/m2 IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing interval is 21 days. Group B: NE x 4 cycles (vinorelbine + epirubicin), vinorelbine: 25 mg/m2 IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing interval is 21 days.
Patients of both groups were performed with diagnostic puncture before treatment and over half of treatment course in order to obtain information about dynamic change of Ki67 and other parameters; Surgery will be performed after 4 cycles of chemotherapy, followed with subsequent adjuvant therapy.
- Conditions
- Breast Cancer
- Being tested
- Vinorelbine plus Epirubicin, Paclitaxel plus Epirubicin
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, TEKT4
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine plus EpirubicinDrug
Evaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations
Paclitaxel plus EpirubicinDrug
standard neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel plus Epirubicin | Active comparator | Paclitaxel plus Epirubicin for 4 cycles, paclitaxel 80 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days. Receives: Drug: Paclitaxel plus Epirubicin |
| Vinorelbine plus Epirubicin | Experimental | Vinorelbine plus Epirubicin for 4 cycles, vinorelbine 25 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days. Receives: Drug: Vinorelbine plus Epirubicin |
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 the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
Measured: 3 years
Secondary outcomes (1)
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, MD.PhD., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628613
- Sponsor's protocol ID
- 20150309
- Status last verified
- Oct 2019
- First submitted
- 5 Dec 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Clinical Trial and Biomarker Analysis of Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin as Neoadjuvant Chemotherapy in Locally Advanced HER2-Negative Breast Cancer With TEKT4 Variations
- ClinicalTrials.gov ID
- NCT02628613
- Acronym / sponsor ID
- 20150309
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, TEKT4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 11 Dec 2015 (estimated)
- 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.
The purpose of this study is to compare the efficiency and safety between paclitaxel combined with epirubicin and vinorelbine combined with epirubicin when used in neoadjuvant chemotherapy for locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variations.
Detailed description
Taxane-based chemotherapy is the cornerstone treating breast cancer, however remarkable percentage of breast cancer patients presents with primary or secondary taxane resistance. Currently no established biomarker has been reported clinically for predicting taxane sensitivity. Our previous study indicated that TEKT4 variation decreased the stability of intracellular microtubule, and TEKT4 variant cells behaves higher resistance to microtubule-stabilizing agents such as taxane, while enhanced sensibility to microtubule depolymerization agents such as vinorelbine. This study is intended to confirm that TEKT4 variation predicts the prognosis of taxane-based chemotherapy through the prospective clinical trials.
This study intends to evaluate the efficiency and safety of two neoadjuvant therapies: paclitaxel combined with epirubicin and vinorelbine combined with epirubicin, in treating locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variation.
Primary endpoint of study: pathologic Complete Response (pCR). Secondary endpoints of the study: Objective response rate (CR+PR). Exploratory endpoint: Based on pretreatment tumor and matched blood samples, the correlation between biomarker and efficiency is explored.
This open single center prospective randomized control study includes patients locally advanced (IIb-IIIc) HER2-negative patients with TEKT4 variation diagnosed with histopathology and Sanger sequencing. Patients randomized to Group A or Group B to receive respective neoadjuvant chemotherapy. Among which Group A: PE x 4 cycles (paclitaxel + epirubicin), paclitaxel: 80 mg/m2 IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing interval is 21 days. Group B: NE x 4 cycles (vinorelbine + epirubicin), vinorelbine: 25 mg/m2 IV on day 1, 8 and 15; epirubicin: 90 mg/m2 IV on day 1, and dosing interval is 21 days.
Patients of both groups were performed with diagnostic puncture before treatment and over half of treatment course in order to obtain information about dynamic change of Ki67 and other parameters; Surgery will be performed after 4 cycles of chemotherapy, followed with subsequent adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel plus Epirubicin | Active comparator | Drug: Paclitaxel plus EpirubicinPaclitaxel plus Epirubicin for 4 cycles, paclitaxel 80 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days. |
| Vinorelbine plus Epirubicin | Experimental | Drug: Vinorelbine plus EpirubicinVinorelbine plus Epirubicin for 4 cycles, vinorelbine 25 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age: 18-70 years old
- Expected survival > 12 months
- Baseline ECOG Performance Status rating 0-1
- Naïve to chemotherapy or hormonal treatments
- Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically
Key exclusion criteria (13 listed)
- Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
- Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
- Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment
- Peripheral neuropathy >1 degree caused by any reason
- History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg);
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 |
|---|---|---|
| Vinorelbine plus EpirubicinEvaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations | Drug | Vinorelbine plus Epirubicin |
| Paclitaxel plus Epirubicinstandard neoadjuvant chemotherapy | Drug | Paclitaxel plus Epirubicin |
Primary outcome
pathologic Complete Response (pCR)
Time frame: 3 years
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
1 secondary outcome
Objective Response Rate (ORR)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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.
Zhimin Shao, MD.PhD. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine plus Epirubicin and Paclitaxel plus Epirubicin in people with 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 19 inclusion and 13 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: finished, as of the sponsor's last update on 1 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 years). 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 1 Nov 2019.