Pathological Conditions, Signs and SymptomsPhase 2NCT05103293
PTC Guiding Neoadjuvant Treatment in Breast Cancer
A Phase 2 study testing patient-derived tumor-like cell clusters drug sensitivity test in people with Pathological Conditions, Signs and Symptoms, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pathological Conditions, Signs and Symptoms
- What is being tested?
- patient-derived tumor-like cell clusters drug sensitivity test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 10 Dec 2023
- 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
- Female between 18 to 70 years old.
- Patients diagnosed with invasive breast cancer by pathology.
- Clinical stage considered as T2-4N0-2M0 .
- HER2 overexpression by IHC or FISH positive.
- Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery.
Who cannot join
- Patients have already accepted any other anti-tumor treatment not included in our project.
- Patients with metastasis are not considered surgery therapy.
- Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study
Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.
Read the detailed description
- Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC drug sensitivity test.
- After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state, all recruited patients will be randomized into the PTC group or the routine treatment group, according to the method of random number table.
- Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene sequencing and PTC drug sensitivity test for biological samples. All samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable.
- Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive breast cancer. All neoadjuvant therapy will be completed before operation if without PD.
- According to postoperative pathological remission, pCR patients in two groups continued to complete adjuvant targeted therapy based on original treatment. For non-pCR patients in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2 negative breast cancer, and T-DM1 or H(P) will be selected.
- All patients will be received radiotherapy or endocrine therapy if necessary.
- Being tested
- patient-derived tumor-like cell clusters drug sensitivity test
- Keywords
- patient-derived tumor-like cell clusters, breast cancer, neoadjuvant therapy, pathologic complete response
- Medical subject headings
- Pathological Conditions, Signs and Symptoms, Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-derived tumor-like cell clusters drug sensitivity testDiagnostic test
Also called PTC
Intervention Description：Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results.
| Study group | Role | What they receive |
|---|---|---|
| PTC group | Experimental | Patients randomized into this group receiving PTC test and choose regimens according to this test results Receives: Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity test |
| Control group | No intervention | Patients randomized into this group receiving routine regimens according to subtypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response
Measured: one month after operation
objective response rate
cCR or PR or SD according to RECIST1.1
Measured: half year after randomize
Secondary outcomes (2)
2y-Disease free survival rate
survive with neither invasive recurrence nor new invasive diseases
Measured: 2year
5y-Disease free survival rate
survive with neither invasive recurrence nor new invasive diseases
Measured: 5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Nov 2021
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological Conditions, Signs and SymptomsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YU Xingfei, Zhejiang Cancer Hospital
- Investigators
- Xingfei Yu, M.D., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103293
- Sponsor's protocol ID
- PTC-breastNAT
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2021
- Last updated
- 27 Dec 2023
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05103293
- Acronym / sponsor ID
- PTC-breastNAT
- Keywords
- patient-derived tumor-like cell clusters, breast cancer, neoadjuvant therapy, pathologic complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 2 Nov 2021 (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.
Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.
Detailed description
- Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC drug sensitivity test.
- After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state, all recruited patients will be randomized into the PTC group or the routine treatment group, according to the method of random number table.
- Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene sequencing and PTC drug sensitivity test for biological samples. All samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable.
- Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive breast cancer. All neoadjuvant therapy will be completed before operation if without PD.
- According to postoperative pathological remission, pCR patients in two groups continued to complete adjuvant targeted therapy based on original treatment. For non-pCR patients in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2 negative breast cancer, and T-DM1 or H(P) will be selected.
- All patients will be received radiotherapy or endocrine therapy if necessary.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTC group | Experimental | Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity testPatients randomized into this group receiving PTC test and choose regimens according to this test results |
| Control group | No intervention | –Patients randomized into this group receiving routine regimens according to subtypes |
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)
- Female between 18 to 70 years old.
- Patients diagnosed with invasive breast cancer by pathology.
- Clinical stage considered as T2-4N0-2M0 .
- HER2 overexpression by IHC or FISH positive.
- Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery.
Key exclusion criteria (3 listed)
- Patients have already accepted any other anti-tumor treatment not included in our project.
- Patients with metastasis are not considered surgery therapy.
- Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons
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 |
|---|---|---|
| patient-derived tumor-like cell clusters drug sensitivity testAlso: PTCIntervention Description：Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results. | Diagnostic test | PTC group |
Primary outcome
pCR rate
Time frame: one month after operation
pathological complete response
objective response rate
Time frame: half year after randomize
cCR or PR or SD according to RECIST1.1
2 secondary outcomes
2y-Disease free survival rate
Time frame: 2year
5y-Disease free survival rate
Time frame: 5year
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 27 Dec 2023.
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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, M.D. principal investigator
Zhejiang Cancer Hospital
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 patient-derived tumor-like cell clusters drug sensitivity test in people with Pathological Conditions, Signs and Symptoms, 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 5 inclusion and 3 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 27 Dec 2023. 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?
pCR rate (time frame: one month after operation). The study lists 2 primary outcomes in all. 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 27 Dec 2023.