Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast CancerCMTNCMBNCT04264468
Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test
An observational study of Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to… Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer
- What is being tested?
- neoadjuvant chemotherapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2019to 1 Mar 2021
- Phase
- Observational
- 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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * Pathologically confirmed new breast cancer (invasive cancer) * Clinical stage II-III * women * Aged 25-80
Who may be able to join
- Pathologically confirmed new breast cancer (invasive cancer)
- Clinical stage II-III
- women
- Aged 25-80
- At least 6 months of follow-up data, clinical diagnosis and treatment information and personal information available for follow-up are complete
- Complete biological samples required for the study: fresh/frozen tissues/white tablets/wax blocks meeting the requirements of the experiment (before neoadjuvant chemotherapy)
- Tumor markers and imaging data were complete
- Neoadjuvant chemotherapy is commonly recommended by the standard NCCN guidelines
Who cannot join
- Subjects refuse to participate
- First diagnosis of stage I or IV breast cancer
- Pathological diagnosis of concurrent (or previous) other malignant tumors
- Prehistory breast cancer
- Younger than 25 or older than 80
- Clinical diagnosis and treatment information or biological samples required by the research institute do not meet the needs of the experiment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Jingjie Li, master, +86-17310738793, li.jingjie@genecast.com.cn
About this study
This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the technical analysis of Mammaprint in patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in tumor tissues and evaluated the accuracy and sensitivity of Mammaprint test in the efficacy of neoadjuvant chemotherapy.A new model for predicting NCT effect of breast cancer with combined risk genes and clinical parameters was established based on the clinical characteristic parameters of patients to study the accuracy and sensitivity of Mammaprint monitoring for prognosis determination of breast cancer patients.
- Being tested
- neoadjuvant chemotherapy
- Keywords
- neoadjuvant chemotherapy, Mammaprint, blueprint, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyCombination product
This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the Mammaprint technology analysis of patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in the tumor tissues and evaluated the accuracy and sensitivity of the Mammaprint test for the efficacy of neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| response group and the non-response group | Received neoadjuvant chemotherapy according to the routine clinical diagnosis and treatment, and evaluated the clinical efficacy once every two cycles of chemotherapy. According to the clinical efficacy, the patients were divided into the neoadjuvant chemotherapy response group and the non-response group (evaluation standard RECIST1.1). Receives: Combination Product: neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Score variation after neoadjuvant chemotherapy
The recurrence score of each subtype
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start14 May 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264468
- Sponsor's protocol ID
- CMTNCMB
- Acronym
- CMTNCMB
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test
- ClinicalTrials.gov ID
- NCT04264468
- Acronym / sponsor ID
- CMTNCMB / CMTNCMB
- Keywords
- neoadjuvant chemotherapy, Mammaprint, blueprint, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 11 Feb 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 prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the technical analysis of Mammaprint in patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in tumor tissues and evaluated the accuracy and sensitivity of Mammaprint test in the efficacy of neoadjuvant chemotherapy.A new model for predicting NCT effect of breast cancer with combined risk genes and clinical parameters was established based on the clinical characteristic parameters of patients to study the accuracy and sensitivity of Mammaprint monitoring for prognosis determination of breast cancer patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| response group and the non-response group | – | Combination Product: neoadjuvant chemotherapyReceived neoadjuvant chemotherapy according to the routine clinical diagnosis and treatment, and evaluated the clinical efficacy once every two cycles of chemotherapy. According to the clinical efficacy, the patients were divided into the neoadjuvant chemotherapy response group and the non-response group (evaluation standard RECIST1.1). |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Pathologically confirmed new breast cancer (invasive cancer) * Clinical stage II-III * women * Aged 25-80
Key inclusion criteria (8 listed)
- Pathologically confirmed new breast cancer (invasive cancer)
- Clinical stage II-III
- women
- Aged 25-80
- At least 6 months of follow-up data, clinical diagnosis and treatment information and personal information available for follow-up are complete
Key exclusion criteria (6 listed)
- Subjects refuse to participate
- First diagnosis of stage I or IV breast cancer
- Pathological diagnosis of concurrent (or previous) other malignant tumors
- Prehistory breast cancer
- Younger than 25 or older than 80
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 |
|---|---|---|
| neoadjuvant chemotherapyThis study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the Mammaprint technology analysis of patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in the tumor tissues and evaluated the accuracy and sensitivity of the Mammaprint test for the efficacy of neoadjuvant chemotherapy | Combination product | response group and the non-response group |
Primary outcome
Recurrence Score variation after neoadjuvant chemotherapy
Time frame: 6 months
The recurrence score of each subtype
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer, run by Zhejiang Cancer 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 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 11 Feb 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.
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 Xing fei Yu, doctoral degree (+86-13588164600, yuxf1177@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Score variation after neoadjuvant chemotherapy (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 11 Feb 2020.