HER2-negative Early Breast CancerPhase 1/2NCT04836156
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
A Phase 1/2 study testing neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer and neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer in people with HER2-negative Early Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-negative Early Breast Cancer
- What is being tested?
- neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer and neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- invasive breast cancer
- HER2 negative
- T2 or node positive
- Eastern Cooperative Oncology Group(ECOG) 0-1
Who cannot join
- stage IV
- inflammatory breast cancer
- Severe chronic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Chaobin Wang, doctor, +86-10-88324010, hzwcb1990@163.com
About this study
Official title: Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now.
Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants.
Read the detailed description
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer participants until now.
Previously, investigators developed a patient-derived tumor-like cell clusters (PTC) in vitro culture technology. It is a cell cluster including tumor cells, mesenchymal cells and lymphocytes, which simulates the tumor microenvironment in vitro. In the preliminary exploration, investigators included 35 early breast cancer participants, the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well. The results have been published.
This study will focus on her2 negative early breast cancer participants. 46 participants will be included. All of them will received in vitro drug sensitivity screening upon PTC before neoadjuvant therapy. The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results. If single-agent chemotherapy is effective in vitro, this drug will be the chemotherapy regimen for the corresponding participants.
- Conditions
- HER2-negative Early Breast Cancer
- Being tested
- neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer, neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancerDrug
Also called docetaxel and carboplatin, docetaxel and epirubicin
The choice of chemotherapy is based on the PTC drug sensitivity results.
neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancerDrug
Also called docetaxel and cyclophosphamide, epirubicin and cyclophosphamide, docetaxel and epirubicin
The choice of chemotherapy is based on the PTC drug sensitivity results.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer | Experimental | Patients with triple negative subtype will receive neoadjuvant chemotherapy based on PTC drug screening. Receives: Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer |
| Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer | Experimental | Patients with luminal like subtype will receive neoadjuvant chemotherapy based on PTC drug screening. Receives: Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response(pCR)
ypT0/is, ypN0
Measured: up to 24 weeks
Secondary outcomes (3)
event-free survival (EFS)
The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause
Measured: 5 years
invasive disease-free survival (IDFS)
The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause
Measured: 5 years
objective response rate
complete response and partial response
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Apr 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Early Breast CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu Wang, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836156
- Sponsor's protocol ID
- PekingUPH10B004
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2021
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04836156
- Acronym / sponsor ID
- PekingUPH10B004
- Conditions
- HER2-negative Early Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 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.
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now.
Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants.
Detailed description
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer participants until now.
Previously, investigators developed a patient-derived tumor-like cell clusters (PTC) in vitro culture technology. It is a cell cluster including tumor cells, mesenchymal cells and lymphocytes, which simulates the tumor microenvironment in vitro. In the preliminary exploration, investigators included 35 early breast cancer participants, the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well. The results have been published.
This study will focus on her2 negative early breast cancer participants. 46 participants will be included. All of them will received in vitro drug sensitivity screening upon PTC before neoadjuvant therapy. The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results. If single-agent chemotherapy is effective in vitro, this drug will be the chemotherapy regimen for the corresponding participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer | Experimental | Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancerPatients with triple negative subtype will receive neoadjuvant chemotherapy based on PTC drug screening. |
| Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer | Experimental | Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancerPatients with luminal like subtype will receive neoadjuvant chemotherapy based on PTC drug screening. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- invasive breast cancer
- HER2 negative
- T2 or node positive
- Eastern Cooperative Oncology Group(ECOG) 0-1
Key exclusion criteria (3 listed)
- stage IV
- inflammatory breast cancer
- Severe chronic disease
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 chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancerAlso: docetaxel and carboplatin, docetaxel and epirubicinThe choice of chemotherapy is based on the PTC drug sensitivity results. | Drug | Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer |
| neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancerAlso: docetaxel and cyclophosphamide, epirubicin and cyclophosphamide, docetaxel and epirubicinThe choice of chemotherapy is based on the PTC drug sensitivity results. | Drug | Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer |
Primary outcome
pathological complete response(pCR)
Time frame: up to 24 weeks
ypT0/is, ypN0
3 secondary outcomes
event-free survival (EFS)
Time frame: 5 years
invasive disease-free survival (IDFS)
Time frame: 5 years
objective response rate
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Shu Wang, doctor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer and neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer in people with HER2-negative Early Breast Cancer, run by Peking University People's 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 4 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: looking for participants now, as of the sponsor's last update on 6 Apr 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaobin Wang, doctor (+86-10-8832-4010, hzwcb1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response(pCR) (time frame: up to 24 weeks). 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 6 Apr 2022.