Breast CancerNCT04249440
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer
An observational study of Breast Cancer and HER2, run by Zhejiang Cancer Hospital.
Trial summary
Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%~60% pCR rate of such a population. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, HER2, Preoperative Systemic Treatment
- What is being tested?
- Preoperative systemic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,067 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Mar 2020
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER2 positive early invasive breast cancer, using trastuzumab for one year both in neoadjuvant or adjuvant setting.
Who may be able to join
- HER2 positive
- early invasive breast cancer (cT1-3N0-1M0)
- using one-year trastuzumab as anti-HER2 treatment
Who cannot join
- Exclude metastasis and recurrent breast cancer
- using trastuzumab less than a year
About this study
Official title: Preoperative Systemic Therapy Versus Upfront Surgery in HER2 Positive Early Breast Cancer: a Prospective Nested Case-control Study in Real World
Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been proved that PST could not improve either disease-free survival (DFS) or overall survival (OS) comparing with postoperatively systemic treatment in total population. We designed a real-world study to investigate the prognosis of anti-HER2 treatment combined with chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer
Read the detailed description
Patients with a diagnosis of HER2 positive early invasive breast cancer (cT1-3N0-1M0), from January 2012 to December 2014 were identified and enrolled continuously. The conditions of HER2-positive expression of primary breast cancer were defined as follows: HER2 3+ by immunohistochemical (IHC) method or HER2 2+ by IHC with a further positive result by fluorescence in situ hybridization (FISH). According to the real upfront treatment, all eligible patients were classified as PST group and surgery group. All the patients accepted standard one-year trastuzumab as anti-HER2 treatment combined with chemotherapy. In the PST group, the effect was evaluated according to RECIST1.1 every two cycles, the patients with clinical complete response (cCR) or partial response (PR) would receive the whole course of chemotherapy, those with stable disease (SD) or progressive disease (PD) would receive surgery promptly. After surgery, all patients underwent irradiation and endocrine therapies if necessary. The pCR was defined as the absence of infiltrating residual invasive disease in the breast and axillary nodes. For those non-pCR patients after PST, intensive adjuvant chemotherapy was not routine treatment except patients with progressive disease.The primary endpoint was DFS defined as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer. Patients suffered disease progress becoming inoperable before surgery were counted as local treatment failures. The second endpoint was OS defined as the time from study entry to death from any cause. All the endpoints were compared between PST group and upfront surgery group, also further analysis according to pathological response status stratified in PST group.
- Conditions
- Breast Cancer, HER2, Preoperative Systemic Treatment
- Being tested
- Preoperative systemic treatment
- Keywords
- breast cancer, HER2, preoperative systemic treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative systemic treatmentProcedure or surgery
Also called neoadjuvant treatment
neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment
| Study group | Role | What they receive |
|---|---|---|
| PST | patient accepts preoperative systemic treatment as upfront strategy Receives: Procedure: Preoperative systemic treatment | |
| upfront surgery | patient accepts upfront surgery and run postoperative systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer
Measured: 5 years
Secondary outcomes (1)
Overall survival
the time from study entry to death from any cause
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 posted31 Jan 2020
- Study start1 Jan 2012
- Primary completion30 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,067 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
- NCT04249440
- Sponsor's protocol ID
- HER2-RWSNeo
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to others
Publications
Yu X, Wang C, Zheng Y, Miao B, Hu J, Shao X, Sheng L, Lin J, Ding Y, Xuan H, Ding Y, Gong L, Feng W, Qin C, Chen D, Yu Y, Yang H. Preoperative Systemic Therapy Versus Upfront Surgery in HER2-Positive Breast Cancer in the Real World. Front Oncol. 2021 Jul 28;11:704842. doi: 10.3389/fonc.2021.704842. eCollection 2021.
PubMed 34395277
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Systemic Therapy Versus Upfront Surgery in HER2 Positive Early Breast Cancer: a Prospective Nested Case-control Study in Real World
- ClinicalTrials.gov ID
- NCT04249440
- Acronym / sponsor ID
- HER2-RWSNeo
- Conditions
- Breast Cancer, HER2, Preoperative Systemic Treatment
- Keywords
- breast cancer, HER2, preoperative systemic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 31 Jan 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.
Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been proved that PST could not improve either disease-free survival (DFS) or overall survival (OS) comparing with postoperatively systemic treatment in total population. We designed a real-world study to investigate the prognosis of anti-HER2 treatment combined with chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer
Detailed description
Patients with a diagnosis of HER2 positive early invasive breast cancer (cT1-3N0-1M0), from January 2012 to December 2014 were identified and enrolled continuously. The conditions of HER2-positive expression of primary breast cancer were defined as follows: HER2 3+ by immunohistochemical (IHC) method or HER2 2+ by IHC with a further positive result by fluorescence in situ hybridization (FISH). According to the real upfront treatment, all eligible patients were classified as PST group and surgery group. All the patients accepted standard one-year trastuzumab as anti-HER2 treatment combined with chemotherapy. In the PST group, the effect was evaluated according to RECIST1.1 every two cycles, the patients with clinical complete response (cCR) or partial response (PR) would receive the whole course of chemotherapy, those with stable disease (SD) or progressive disease (PD) would receive surgery promptly. After surgery, all patients underwent irradiation and endocrine therapies if necessary. The pCR was defined as the absence of infiltrating residual invasive disease in the breast and axillary nodes. For those non-pCR patients after PST, intensive adjuvant chemotherapy was not routine treatment except patients with progressive disease.The primary endpoint was DFS defined as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer. Patients suffered disease progress becoming inoperable before surgery were counted as local treatment failures. The second endpoint was OS defined as the time from study entry to death from any cause. All the endpoints were compared between PST group and upfront surgery group, also further analysis according to pathological response status stratified in PST group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PST | – | Procedure: Preoperative systemic treatmentpatient accepts preoperative systemic treatment as upfront strategy |
| upfront surgery | – | –patient accepts upfront surgery and run postoperative systemic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 positive early invasive breast cancer, using trastuzumab for one year both in neoadjuvant or adjuvant setting.
Key inclusion criteria (3 listed)
- HER2 positive
- early invasive breast cancer (cT1-3N0-1M0)
- using one-year trastuzumab as anti-HER2 treatment
Key exclusion criteria (2 listed)
- Exclude metastasis and recurrent breast cancer
- using trastuzumab less than a year
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 |
|---|---|---|
| Preoperative systemic treatmentAlso: neoadjuvant treatmentneoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment | Procedure or surgery | PST |
Primary outcome
Disease free survival
Time frame: 5 years
as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer
1 secondary outcome
Overall survival
Time frame: 5 years
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 28 Sep 2020.
- Derived from this study: PubMed 34395277Yu X, Wang C, Zheng Y, Miao B, Hu J, Shao X, Sheng L, Lin J, Ding Y, Xuan H, Ding Y, Gong L, Feng W, Qin C, Chen D, Yu Y, Yang H. Preoperative Systemic Therapy Versus Upfront Surgery in HER2-Positive Breast Cancer in the Real World. Front Oncol. 2021 Jul 28;11:704842. doi: 10.3389/fonc.2021.704842. eCollection 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to others
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2, 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 3 inclusion and 2 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 28 Sep 2020. 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.
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?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249440, which also lists 1 linked publication.
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 28 Sep 2020.