Breast NeoplasmsCSNCT05285332
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy
A study testing surgical treatment 1, surgical treatment 2 and Systemic therapy in people with Breast Neoplasms and Treatment, run by Changhai Hospital.
Trial summary
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients. There is no clinical study on the classification after systemic treatment of de novo stage IV breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Treatment, Metastatic Breast Cancer
- What is being tested?
- surgical treatment 1, surgical treatment 2 and Systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 May 2031
- Phase
- Interventional
- 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
- Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- ECOG-PS 0-2.
- Bone marrow, liver and kidney should be fully functional.
- Patients didn't received the locoregional surgery of the primary tumor in de novo.
- For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
Who cannot join
- Accompanied with other primary malignant tumors.
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients. There is no clinical study on the classification after systemic treatment of de novo stage IV breast cancer patients. In fact, the clinical stage of tumor can change with the change of treatment. For example, the stage Ⅲ of locally advanced breast cancer can down-staging to the stage Ⅱ after systemic treatment. Similarly, patients with stage Ⅳ can down-staging to stage Ⅱ or stage Ⅲ after systemic treatment. At this time, the patient can receive surgical treatment. Therefore, this study is to first treat de novo stage IV breast cancer patients with systemic treatment, according to the response after systemic treatment to give different treatment measures（surgery or continued systemic treatment）. The investigators hope that this study will provide new ideas for the treatment of de novo stage IV breast cancer and other de novo stage IV cancers.
Read the detailed description
This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of surgical treatment. According to the tumour heterogeneity characteristics between the primary and metastatic tumours, the investigators investigated the following A, B and C scenarios. After systemic therapy in patients with de novo metastatic breast cancer, the outcomes of primary and metastatic lesions were mainly divided into four categories (Fig. 1a, b, c, d). It is worth noting that after treatment, the four conditions of a, b, c, and d may alternate with the progression of the tumour or modification of the treatment plan. Therefore, only a proactive evaluation and timely treatment can identify the time window for tumour treatment. The time window for surgical treatment is important because, once missed, the tumour may progress with new metastatic lesions. Figure 1-a: Imaging study indicates complete remission of primary and metastatic tumours. Diagnostic surgical treatment can be performed to determine whether a pathologic complete response (PCR) is achieved and to develop a subsequent treatment plan. Figure 1-b: Imaging study indicates complete remission of the metastatic tumour with residual primary tumour. The state of the patient in this scenario could be equivalent to that of patients with early resectable breast cancer. Surgical treatment of the primary tumour should be promptly performed. Figure 1-c: Complete remission of the primary and residual metastatic tumour. Surgical treatment can be selected for isolated and resectable metastatic tumour. Figure 1-d: No remission or even progression of the primary and metastatic tumours. The systemic treatment plan should be replaced, and the surgical treatment should not be considered.
- Conditions
- Breast Neoplasms, Treatment, Metastatic Breast Cancer, Survival
- Being tested
- surgical treatment 1, surgical treatment 2, Systemic therapy
- Keywords
- Breast Neoplasms, de-novo metastatic breast cancer, surgical 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.
surgical treatment 1Procedure or surgery
Also called surgery 1
Mastectomy OR Breast conserving surgery
surgical treatment 2Procedure or surgery
Also called surgery 2
Resection of metastasis
Systemic therapyDrug
Endocrine therapy or chemotherapy or targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 Primary and metastatic lesions PCR | Experimental | surgery 1 Mastectomy OR Breast conserving surgery Receives: Procedure: surgical treatment 1 |
| 2 Primary lesions NPCR and metastatic lesions PCR | Experimental | surgery 1 Mastectomy OR Breast conserving surgery Receives: Procedure: surgical treatment 1 |
| 3 Primary lesions PCR and metastatic lesions NPCR | Experimental | surgery 2 Resection of metastasis Receives: Procedure: surgical treatment 2 |
| 4 Primary lesions NPCR and metastatic lesions NPCR | Experimental | Systemic therapy Endocrine therapy or chemotherapy or targeted therapy Receives: Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
Measured: 5 years
Secondary outcomes (2)
Distant progression free survival
Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.
Measured: 5 years
Locoregional progression free survival
Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
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 posted17 Mar 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Changhai 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Yu, Changhai Hospital
- Investigators
- YU YUE, doctor, Study chair, Department of thyroid and breast surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285332
- Sponsor's protocol ID
- ChanghaiHTB
- Acronym
- CS
- Status last verified
- Jul 2022
- First submitted
- 9 Mar 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery
- ClinicalTrials.gov ID
- NCT05285332
- Acronym / sponsor ID
- CS / ChanghaiHTB
- Conditions
- Breast Neoplasms, Treatment, Metastatic Breast Cancer, Survival
- Keywords
- Breast Neoplasms, de-novo metastatic breast cancer, surgical treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 17 Mar 2022 (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.
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients. There is no clinical study on the classification after systemic treatment of de novo stage IV breast cancer patients. In fact, the clinical stage of tumor can change with the change of treatment. For example, the stage Ⅲ of locally advanced breast cancer can down-staging to the stage Ⅱ after systemic treatment. Similarly, patients with stage Ⅳ can down-staging to stage Ⅱ or stage Ⅲ after systemic treatment. At this time, the patient can receive surgical treatment. Therefore, this study is to first treat de novo stage IV breast cancer patients with systemic treatment, according to the response after systemic treatment to give different treatment measures（surgery or continued systemic treatment）. The investigators hope that this study will provide new ideas for the treatment of de novo stage IV breast cancer and other de novo stage IV cancers.
Detailed description
This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of surgical treatment. According to the tumour heterogeneity characteristics between the primary and metastatic tumours, the investigators investigated the following A, B and C scenarios. After systemic therapy in patients with de novo metastatic breast cancer, the outcomes of primary and metastatic lesions were mainly divided into four categories (Fig. 1a, b, c, d). It is worth noting that after treatment, the four conditions of a, b, c, and d may alternate with the progression of the tumour or modification of the treatment plan. Therefore, only a proactive evaluation and timely treatment can identify the time window for tumour treatment. The time window for surgical treatment is important because, once missed, the tumour may progress with new metastatic lesions. Figure 1-a: Imaging study indicates complete remission of primary and metastatic tumours. Diagnostic surgical treatment can be performed to determine whether a pathologic complete response (PCR) is achieved and to develop a subsequent treatment plan. Figure 1-b: Imaging study indicates complete remission of the metastatic tumour with residual primary tumour. The state of the patient in this scenario could be equivalent to that of patients with early resectable breast cancer. Surgical treatment of the primary tumour should be promptly performed. Figure 1-c: Complete remission of the primary and residual metastatic tumour. Surgical treatment can be selected for isolated and resectable metastatic tumour. Figure 1-d: No remission or even progression of the primary and metastatic tumours. The systemic treatment plan should be replaced, and the surgical treatment should not be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Primary and metastatic lesions PCR | Experimental | Procedure: surgical treatment 1surgery 1 Mastectomy OR Breast conserving surgery |
| 2 Primary lesions NPCR and metastatic lesions PCR | Experimental | Procedure: surgical treatment 1surgery 1 Mastectomy OR Breast conserving surgery |
| 3 Primary lesions PCR and metastatic lesions NPCR | Experimental | Procedure: surgical treatment 2surgery 2 Resection of metastasis |
| 4 Primary lesions NPCR and metastatic lesions NPCR | Experimental | Drug: Systemic therapySystemic therapy Endocrine therapy or chemotherapy or targeted therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- ECOG-PS 0-2.
- Bone marrow, liver and kidney should be fully functional.
- Patients didn't received the locoregional surgery of the primary tumor in de novo.
- For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
Key exclusion criteria (4 listed)
- Accompanied with other primary malignant tumors.
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
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 |
|---|---|---|
| surgical treatment 1Also: surgery 1Mastectomy OR Breast conserving surgery | Procedure or surgery | 1 Primary and metastatic lesions PCR, 2 Primary lesions NPCR and metastatic lesions PCR |
| surgical treatment 2Also: surgery 2Resection of metastasis | Procedure or surgery | 3 Primary lesions PCR and metastatic lesions NPCR |
| Systemic therapyEndocrine therapy or chemotherapy or targeted therapy | Drug | 4 Primary lesions NPCR and metastatic lesions NPCR |
Primary outcome
Overall survival
Time frame: 5 years
Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
2 secondary outcomes
Distant progression free survival
Time frame: 5 years
Locoregional progression free survival
Time frame: 5 years
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 19 Jul 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.
YU YUE, doctor study chair
Department of thyroid and breast surgery, Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing surgical treatment 1, surgical treatment 2 and Systemic therapy in people with Breast Neoplasms and Treatment, run by Changhai 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 4 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: opening soon, as of the sponsor's last update on 19 Jul 2022. 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?
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 YU YUE, doctor (+86 13564261349, dr-array@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 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?
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 19 Jul 2022.