Breast CancerPhase 2NCT04302441
A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy
A Phase 2 study testing Vinorelbine and Capecitabine in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy 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 and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2016to 30 Jun 2021
- 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 (at least 6 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs combined with trastuzumab), 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 Her2 receptor positive (Specific definition: immunohistochemical detection of Her2 3+ or Her2 2 + but after FISH or CISH tested is positive).
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- 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.
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- 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.
Zhi-Min Shao contact
China1 site, 1 recruiting
- Recruiting
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com
About this study
Official title: A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy
This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy
- Conditions
- Breast Cancer
- Being tested
- Vinorelbine, Capecitabine
- Keywords
- non-pCR, HER2 positive, vinorelbine, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
vinorelbine 25mg/m2 on day 1 and 8,every 3 weeks
CapecitabineDrug
Capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| NXH group | Experimental | Patients should receive four cycles of NXH regimen (vinorelbine at 25 mg/m2 iv infusion on day 1 and day 8 plus capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle, trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year). Receives: Drug: Vinorelbine; Drug: Capecitabine |
| H group | No intervention | Patients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
Recurrence free survival
Recurrence free survival is calculated from surgery to the first recurrence
Measured: 3 year
Distant disease free survival
Distant disease free survival is calculated from surgery to the first distant metastasis.
Measured: 3 year
Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 5=3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start10 Nov 2016
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Ming Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302441
- Sponsor's protocol ID
- FUSCC-162-9
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04302441
- Acronym / sponsor ID
- FUSCC-162-9
- Conditions
- Breast Cancer
- Keywords
- non-pCR, HER2 positive, vinorelbine, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXH group | Experimental | Drug: Vinorelbine, Drug: CapecitabinePatients should receive four cycles of NXH regimen (vinorelbine at 25 mg/m2 iv infusion on day 1 and day 8 plus capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle, trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year). |
| H group | No intervention | –Patients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 (at least 6 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs combined with trastuzumab), 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Vinorelbinevinorelbine 25mg/m2 on day 1 and 8,every 3 weeks | Drug | NXH group |
| CapecitabineCapecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle | Drug | NXH group |
Primary outcome
Disease free survival
Time frame: 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
3 secondary outcomes
Recurrence free survival
Time frame: 3 year
Distant disease free survival
Time frame: 3 year
Overall survival
Time frame: 5=3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Zhi-Min Shao contact
Zhi-Ming Shao 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 and Capecitabine 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 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 10 Mar 2020. 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?
Contact Zhi-Ming Shao, M.D. (862164175590 ext. 862164175590, zhimingshao@yahoo.com), or a site near the patient. 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?
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 10 Mar 2020.