Breast CancerPhase 2RSBNATNCT03638648
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by Zhejiang Cancer Hospital.
Trial summary
The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in 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?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 Dec 2022
- 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
- Invasive breast cancer at the first diagnosed
- Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles
- Neoadjuvant chemotherapy regimen should include anthracyclines and taxane
- Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy
- Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor)
Who cannot join
- Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy
- Pregnant breast cancer
- IHC or FISH test of primary tumor confirmed HER2 positive at anytime
- Complete fewer than 6 cycles chemotherapy before surgery
- Deficiency of surgery after neoadjuvant
- Contraindication of chemotherapy or surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment
The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy. It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients. Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.
Read the detailed description
This study is designed as stratified cluster randomized, parallel-control research. The HR+HER2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pCR are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery. After enrollment, the patients were stratified according to multiple gene test based recurrence risk level (High risk or Low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (Capecitabine) group or negative control group. The primary endpoint is 2-year disease free survival. The second endpoint is 5-year disease free survival (DFS), 2-year overall survival (OS), 5-year OS, safety of additional chemotherapy. The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine
- Keywords
- breast cancer, neoadjuvant, multiple gene detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called additional chemotherapy
Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Low risk Capecitabine | Active comparator | Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine. Receives: Drug: Capecitabine |
| Low risk control | No intervention | Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy. |
| High risk Capecitabine | Experimental | Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine. Receives: Drug: Capecitabine |
| High risk control | No intervention | Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year DFS
disease-free survival rate in 2 years
Measured: 2 years after randomized
Secondary outcomes (4)
5-year DFS
disease-free survival rate in 5 years
Measured: 5 years after randomized
2-year OS
overall survival rate in 2 years
Measured: 2 years after randomized
5-year OS
overall survival rate in 5 years
Measured: 5 years after randomized
Aside effect
any aside effect induced by additional chemotherapy (Capecitabine)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Nov 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2022 (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 Zhejiang Cancer HospitalThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingfei Yu, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638648
- Sponsor's protocol ID
- RS-NAT01
- Acronym
- RSBNAT
- Status last verified
- Sep 2019
- First submitted
- 16 Aug 2018
- Last updated
- 10 Sep 2019
- 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 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT03638648
- Acronym / sponsor ID
- RSBNAT / RS-NAT01
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant, multiple gene detection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Aug 2018 (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.
The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy. It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients. Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.
Detailed description
This study is designed as stratified cluster randomized, parallel-control research. The HR+HER2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pCR are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery. After enrollment, the patients were stratified according to multiple gene test based recurrence risk level (High risk or Low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (Capecitabine) group or negative control group. The primary endpoint is 2-year disease free survival. The second endpoint is 5-year disease free survival (DFS), 2-year overall survival (OS), 5-year OS, safety of additional chemotherapy. The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk Capecitabine | Active comparator | Drug: CapecitabinePatients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine. |
| Low risk control | No intervention | –Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy. |
| High risk Capecitabine | Experimental | Drug: CapecitabinePatients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine. |
| High risk control | No intervention | –Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Invasive breast cancer at the first diagnosed
- Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles
- Neoadjuvant chemotherapy regimen should include anthracyclines and taxane
- Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy
- Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor)
Key exclusion criteria (6 listed)
- Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy
- Pregnant breast cancer
- IHC or FISH test of primary tumor confirmed HER2 positive at anytime
- Complete fewer than 6 cycles chemotherapy before surgery
- Deficiency of surgery after neoadjuvant
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 |
|---|---|---|
| CapecitabineAlso: additional chemotherapyCapecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles | Drug | High risk Capecitabine, Low risk Capecitabine |
Primary outcome
2-year DFS
Time frame: 2 years after randomized
disease-free survival rate in 2 years
4 secondary outcomes
5-year DFS
Time frame: 5 years after randomized
2-year OS
Time frame: 2 years after randomized
5-year OS
Time frame: 5 years after randomized
Aside effect
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- 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.
Xingfei Yu, MD principal investigator
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by Zhejiang Cancer Hospital.
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 5 inclusion and 6 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Xingfei Yu, MD (8657188122001, yuxf1177@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year DFS (time frame: 2 years after randomized). 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 Sep 2019.