Malignant Phyllodes Tumor of the BreastNCT07903181
Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast
An observational study of Malignant Phyllodes Tumor of the Breast, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Malignant phyllodes tumor of the breast is a rare fibroepithelial tumor. Patients with metastatic or unresectable disease have limited systemic treatment options, and there remains a need for biomarkers that can dynamically reflect disease changes during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Phyllodes Tumor of the Breast
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jun 2029
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists primarily of adult women with pathologically confirmed advanced malignant phyllodes tumors of the breast who have distant metastatic disease or are currently considered unsuitable for curative surgery. Participants will be starting or receiving a current line of systemic therapy and must not have experienced a PFS event at enrollment. The prospective main cohort will include approximately 50 participants. A small number of patients with pre-existing clinical data and archived blood samples who experienced a PFS event before formal enrollment may be included separately as retrospective exploratory cases and will not be included in the primary analyses.
Who may be able to join
- Female patients aged 18 years or older.
- Pathologically confirmed malignant phyllodes tumor of the breast.
- Distant metastatic disease, or disease considered unsuitable for curative surgery based on multidisciplinary discussion or investigator assessment.
- Planning to start the current line of systemic therapy and able to complete baseline ctDNA blood collection and the required baseline assessments before initiation of that treatment line.
- At least one lesion available for imaging follow-up and assessment of disease progression.
- No prior tumor tissue whole-exome sequencing (WES), with WES independently determined by the treating physician to be clinically indicated based on the patient's own diagnostic and treatment needs; the patient must be able to undergo clinical WES and provide the resulting WES data and the necessary authorized molecular data required for establishment of an individualized ctDNA monitoring panel.
- Estimated life expectancy greater than 3 months, with clinical status considered adequate by the investigator to complete study-related blood collection, imaging assessments, and follow-up.
- The participant voluntarily agrees to participate in the study and provides written informed consent.
Who cannot join
- 1.Insufficient candidate somatic variants available for individualized tracking in the clinical WES results, or molecular data that do not meet the requirements for establishment of an individualized ctDNA monitoring panel.
- Presence of another active malignancy that may affect assessment of the study endpoints, except for cured carcinoma in situ, non-melanoma skin cancer, or a prior malignancy judged by the investigator not to affect study endpoint assessment.
- Severe active infection, severe cardiac, pulmonary, hepatic, or renal dysfunction, uncontrolled systemic disease, or any other clinical condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
- Pregnant or breastfeeding women.
- Inability to understand the study, provide informed consent, or comply with follow-up because of psychiatric, cognitive, social, or other factors.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
- The current systemic treatment line has already started and baseline ctDNA blood collection could not be completed before initiation of that treatment line.
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
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Yan Nie, PhD, +86-15876535276, nieyan7@mail.sysu.edu.cn
About this study
Official title: A Prospective Multicenter Cohort Study of ctDNA Dynamics for Evaluating Treatment Response and Prognostic Value in Advanced Malignant Phyllodes Tumors of the Breast
Malignant phyllodes tumor of the breast is a rare fibroepithelial tumor. Patients with metastatic or unresectable disease have limited systemic treatment options, and there remains a need for biomarkers that can dynamically reflect disease changes during treatment. Circulating tumor DNA (ctDNA) may provide additional information on tumor burden and disease progression through a minimally invasive blood-based approach.
This prospective, multicenter, observational cohort study will enroll approximately 50 patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently not candidates for curative surgery and are planning to start systemic therapy. Peripheral blood samples will be collected before treatment and at predefined time points during the current systemic treatment line, including time points corresponding to routine imaging assessments. Individualized tumor-informed ctDNA monitoring panels will be established using patient-specific somatic variants identified from tumor whole-exome sequencing obtained during routine clinical care.
The study will primarily evaluate the relationship between dynamic changes in ctDNA during the current systemic treatment line and progression-free survival (PFS), and will explore the potential value of longitudinal ctDNA monitoring for disease monitoring and prognostic assessment in advanced malignant phyllodes tumors. Study ctDNA results will not be used independently to guide clinical treatment decisions.
Read the detailed description
Malignant phyllodes tumor (MPT) of the breast is a rare fibroepithelial neoplasm with heterogeneous clinical behavior. Patients with metastatic disease or disease that is not amenable to curative surgery have limited systemic treatment options and generally have an unfavorable prognosis. During systemic therapy, there remains a need for biomarkers that can dynamically reflect changes in tumor burden and disease status.
Circulating tumor DNA (ctDNA) contains tumor-derived molecular alterations detectable in peripheral blood and may provide a minimally invasive approach for longitudinal monitoring of tumor burden. Tumor-informed ctDNA assays use patient-specific somatic variants identified from tumor genomic sequencing to establish individualized monitoring panels, allowing longitudinal tracking of molecular changes during treatment. Evidence regarding longitudinal ctDNA monitoring in malignant phyllodes tumors remains limited.
This is a prospective, multicenter, observational, single-cohort study enrolling approximately 50 patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently considered unsuitable for curative surgery and who are planning to start systemic therapy. The current systemic treatment line will serve as the principal observation window. Baseline peripheral blood will be collected before initiation of the treatment line, followed by longitudinal blood collection before the second treatment cycle, before the third treatment cycle, and at subsequent time points corresponding to routine CT or MRI assessments. When feasible, an additional blood sample will be collected at radiologically confirmed disease progression.
Individualized tumor-informed ctDNA monitoring panels will be established using patient-specific somatic variants identified from tumor whole-exome sequencing obtained during routine clinical care. A matched normal sample will be collected at the first study blood draw to support filtering of germline variants and signals potentially related to clonal hematopoiesis. Longitudinal ctDNA assessments will include ctDNA detection status, ctDNA level, and plasma variant allele frequency.
The study will focus on the relationship between baseline ctDNA status, early changes in ctDNA during treatment, and ctDNA patterns at blood collection time points corresponding to routine imaging assessments, and progression-free survival (PFS) during the current systemic treatment line. The study aims to provide exploratory evidence regarding the potential value of longitudinal ctDNA monitoring for disease monitoring and prognostic assessment in patients with advanced malignant phyllodes tumors of the breast.
For a small subset of patients who become candidates for surgery or local treatment after systemic therapy, additional perioperative blood sampling may be performed before treatment, 2 to 4 weeks after surgery, and at subsequent imaging assessment time points as an exploratory analysis.
All systemic treatment decisions and routine imaging assessments will be made according to standard clinical practice. Participation in this study will not determine the choice of systemic therapy. Study ctDNA results will not replace standard clinical or imaging assessments and will not be used independently to guide treatment decisions.
- Conditions
- Malignant Phyllodes Tumor of the Breast
- Keywords
- Circulating Tumor DNA, ctDNA, Tumor-Informed ctDNA, Malignant Phyllodes Tumor, Advanced Phyllodes Tumor, Progression-Free Survival, PFS
- Medical subject headings
- Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Malignant Phyllodes Tumor Cohort | Patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently considered unsuitable for curative surgery and who are starting or receiving a current line of systemic therapy without a progression-free survival event at enrollment. Participants included in the primary longitudinal analysis must have a valid pretreatment blood sample obtained before the first dose of the current systemic treatment line. Participants will undergo longitudinal ctDNA monitoring, imaging assessment, and clinical follow-up during the current treatment line. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival According to Early ctDNA Status Transition Patterns
Circulating tumor DNA (ctDNA) detection status at pretreatment baseline (T0) and before cycle 3 (T2) defines four groups: negative at both visits, negative-to-positive, positive-to-negative, and positive at both visits. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause. Censoring follows the study protocol. Comparisons include participants with valid paired results who remain event-free at T2. T2 status is applied only after collection of the T2 sample, with appropriate risk-set handling to avoid immortal time bias. PFS will be summarized across the four groups; exploratory Cox regression will estimate hazard ratios and 95% confidence intervals if the number of events permits. Otherwise, descriptive survival results will be reported.
Measured: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA at pretreatment baseline and before Cycle 3. Cycle length varies by regimen (usually 28 days; sometimes 21 days or other durations).
Secondary outcomes (6)
Progression-Free Survival According to Baseline ctDNA Detection Status
At pretreatment baseline (T0), circulating tumor DNA (ctDNA) detection status is classified as positive or negative according to prespecified assay criteria. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the study protocol. PFS will be summarized by baseline ctDNA status. If the number of events permits, Cox regression will estimate the hazard ratio for ctDNA-positive versus ctDNA-negative participants with a 95% confidence interval.
Measured: From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA status measured before the first treatment dose.
Progression-Free Survival According to Baseline ctDNA Concentration
Circulating tumor DNA (ctDNA) concentration is measured before treatment initiation (T0) in haploid genome equivalents per milliliter (hGE/mL). Baseline concentration is evaluated as a continuous predictor without a prespecified high/low cutoff. Reliably quantifiable positive concentrations will be log2-transformed for exploratory analysis. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. A Cox model will estimate the hazard ratio and 95% confidence interval if data permit. Nondetectable or nonquantifiable values will be handled according to prespecified rules.
Measured: From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA concentration measured before the first treatment dose.
Progression-Free Survival According to ctDNA Status Transitions Before Cycle 2
Circulating tumor DNA (ctDNA) detection status at pretreatment baseline (T0) and before cycle 2 (T1) defines four groups: negative at both visits, negative-to-positive, positive-to-negative, and positive at both visits. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. Comparisons include participants with valid T0 and T1 results who remain event-free at T1. T1 status enters the analysis only after T1 sampling, with appropriate risk-set handling. PFS will be summarized by group; exploratory Cox regression will be performed if event counts permit.
Measured: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to the ctDNA Concentration Ratio at T1 Versus Baseline
Circulating tumor DNA (ctDNA) concentration is measured in haploid genome equivalents per milliliter (hGE/mL) at pretreatment baseline (T0) and before cycle 2 (T1). For participants with reliably quantifiable concentrations at both visits and T0 > 0, the T1/T0 ratio is calculated as T1 concentration divided by T0 concentration; the ratio is unitless. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. The ratio will be evaluated as a continuous predictor in exploratory Cox regression if data permit, using only risk time after T1 sampling. Invalid or nonquantifiable ratios will not be assigned arbitrary values.
Measured: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to the ctDNA Concentration Ratio at T2 Versus Baseline
Circulating tumor DNA (ctDNA) concentration is measured in haploid genome equivalents per milliliter (hGE/mL) at pretreatment baseline (T0) and before cycle 3 (T2). For participants with reliably quantifiable concentrations at both visits and T0 > 0, the T2/T0 ratio is calculated as T2 concentration divided by T0 concentration; the ratio is unitless. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. The ratio will be evaluated as a continuous predictor in exploratory Cox regression if data permit, using only risk time after T2 sampling. Invalid or nonquantifiable ratios will not be assigned arbitrary values.
Measured: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 3. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to Time-Updated ctDNA Detection Status at Subsequent Imaging Visits
Circulating tumor DNA (ctDNA) detection status (positive or negative) is assessed at routine CT/MRI imaging visits after T2 (T3 and later) during the current systemic treatment line. Progression-free survival (PFS), measured in months, is the time from treatment-line initiation to first radiologically confirmed disease progression or death from any cause; censoring follows the protocol. If sufficient data are available, a Cox model with ctDNA status as a time-varying covariate will estimate the hazard ratio for positive versus negative status and its 95% confidence interval. Status is updated at the actual sampling date; only previously collected samples are used to evaluate subsequent risk. If modeling is not feasible, findings will be descriptive.
Measured: From treatment-line initiation to imaging-confirmed progression, death, or censoring (up to 24 months); ctDNA at routine CT/MRI visits following pre-cycle 3 sampling. Cycle length varies by regimen (usually 28 days; may be 21 days or other lengths).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant Phyllodes Tumor of the BreastStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, First Affiliated Hospital, Sun Yat-Sen University, Peking University Shenzhen Hospital, First People's Hospital of Foshan, Foshan Women's and Children's Hospital
- Responsible party
- Principal investigator, Yan Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903181
- Sponsor's protocol ID
- SYSKY-2026-793-01
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hrebien S, Citi V, Garcia-Murillas I, Cutts R, Fenwick K, Kozarewa I, McEwen R, Ratnayake J, Maudsley R, Carr TH, de Bruin EC, Schiavon G, Oliveira M, Turner N. Early ctDNA dynamics as a surrogate for progression-free survival in advanced breast cancer in the BEECH trial. Ann Oncol. 2019 Jun 1;30(6):945-952. doi: 10.1093/annonc/mdz085.
PubMed 30860573Bansal R, Adeyelu T, Elliott A, Tan AR, Ribeiro JR, Meisel J, Oberley MJ, Graff SL, Sledge GW Jr, Grilley-Olson JE, Sammons SL, Rosenberger LH. Genomic Landscape of Malignant Phyllodes Tumors Identifies Subsets for Targeted Therapy. JCO Precis Oncol. 2024 Dec;8:e2400289. doi: 10.1200/PO.24.00289. Epub 2024 Dec 5.
PubMed 39637336Rosenberger LH, Riedel RF, Diego EJ, Nash AL, Grilley-Olson JE, Danziger NA, Sokol ES, Ross JS, Sammons SL. Genomic landscape of malignant phyllodes tumors reveals multiple targetable opportunities. Oncologist. 2024 Dec 6;29(12):1024-1031. doi: 10.1093/oncolo/oyae218.
PubMed 39191445Mosele MF, Westphalen CB, Stenzinger A, Barlesi F, Bayle A, Bieche I, Bonastre J, Castro E, Dienstmann R, Kramer A, Czarnecka AM, Meric-Bernstam F, Michiels S, Miller R, Normanno N, Reis-Filho J, Remon J, Robson M, Rouleau E, Scarpa A, Serrano C, Mateo J, Andre F. Recommendations for the use of next-generation sequencing (NGS) for patients with advanced cancer in 2024: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2024 Jul;35(7):588-606. doi: 10.1016/j.annonc.2024.04.005. Epub 2024 May 27.
PubMed 38834388Bishr MK, Humphreys A, Ahmed M, Cox K, Hughes A, Isherwood J, Pinder SE, Remoundos DD, Sawyer E, Tamimy MS, Whisker L. Contemporary management of phyllodes tumours of the breast: recommendations from the UK Association of Breast Surgery. Br J Surg. 2025 Aug 1;112(8):znaf152. doi: 10.1093/bjs/znaf152. No abstract available.
PubMed 40847758Reason EH, Aiduk MD, Nash AL, McDuff SGR, Renner D, Kollipara RK, Satta S, Velichko S, Kalashnikova E, Rodriguez AA, Liu MC, Strickler JH, Grilley-Olson JE, Rosenberger LH. Circulating Tumor DNA (ctDNA) is Reliably Detected in Patients with Metastatic Malignant Phyllodes Tumors, a Feasibility Study. Ann Surg Oncol. 2025 Oct;32(11):8299-8308. doi: 10.1245/s10434-025-17851-3. Epub 2025 Jul 23.
PubMed 40702203
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study of ctDNA Dynamics for Evaluating Treatment Response and Prognostic Value in Advanced Malignant Phyllodes Tumors of the Breast
- ClinicalTrials.gov ID
- NCT07903181
- Acronym / sponsor ID
- SYSKY-2026-793-01
- Conditions
- Malignant Phyllodes Tumor of the Breast
- Keywords
- Circulating Tumor DNA, ctDNA, Tumor-Informed ctDNA, Malignant Phyllodes Tumor, Advanced Phyllodes Tumor, Progression-Free Survival, PFS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, First Affiliated Hospital, Sun Yat-Sen University, Peking University Shenzhen Hospital, First People's Hospital of Foshan, Foshan Women's and Children's Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
Malignant phyllodes tumor of the breast is a rare fibroepithelial tumor. Patients with metastatic or unresectable disease have limited systemic treatment options, and there remains a need for biomarkers that can dynamically reflect disease changes during treatment. Circulating tumor DNA (ctDNA) may provide additional information on tumor burden and disease progression through a minimally invasive blood-based approach.
This prospective, multicenter, observational cohort study will enroll approximately 50 patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently not candidates for curative surgery and are planning to start systemic therapy. Peripheral blood samples will be collected before treatment and at predefined time points during the current systemic treatment line, including time points corresponding to routine imaging assessments. Individualized tumor-informed ctDNA monitoring panels will be established using patient-specific somatic variants identified from tumor whole-exome sequencing obtained during routine clinical care.
The study will primarily evaluate the relationship between dynamic changes in ctDNA during the current systemic treatment line and progression-free survival (PFS), and will explore the potential value of longitudinal ctDNA monitoring for disease monitoring and prognostic assessment in advanced malignant phyllodes tumors. Study ctDNA results will not be used independently to guide clinical treatment decisions.
Detailed description
Malignant phyllodes tumor (MPT) of the breast is a rare fibroepithelial neoplasm with heterogeneous clinical behavior. Patients with metastatic disease or disease that is not amenable to curative surgery have limited systemic treatment options and generally have an unfavorable prognosis. During systemic therapy, there remains a need for biomarkers that can dynamically reflect changes in tumor burden and disease status.
Circulating tumor DNA (ctDNA) contains tumor-derived molecular alterations detectable in peripheral blood and may provide a minimally invasive approach for longitudinal monitoring of tumor burden. Tumor-informed ctDNA assays use patient-specific somatic variants identified from tumor genomic sequencing to establish individualized monitoring panels, allowing longitudinal tracking of molecular changes during treatment. Evidence regarding longitudinal ctDNA monitoring in malignant phyllodes tumors remains limited.
This is a prospective, multicenter, observational, single-cohort study enrolling approximately 50 patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently considered unsuitable for curative surgery and who are planning to start systemic therapy. The current systemic treatment line will serve as the principal observation window. Baseline peripheral blood will be collected before initiation of the treatment line, followed by longitudinal blood collection before the second treatment cycle, before the third treatment cycle, and at subsequent time points corresponding to routine CT or MRI assessments. When feasible, an additional blood sample will be collected at radiologically confirmed disease progression.
Individualized tumor-informed ctDNA monitoring panels will be established using patient-specific somatic variants identified from tumor whole-exome sequencing obtained during routine clinical care. A matched normal sample will be collected at the first study blood draw to support filtering of germline variants and signals potentially related to clonal hematopoiesis. Longitudinal ctDNA assessments will include ctDNA detection status, ctDNA level, and plasma variant allele frequency.
The study will focus on the relationship between baseline ctDNA status, early changes in ctDNA during treatment, and ctDNA patterns at blood collection time points corresponding to routine imaging assessments, and progression-free survival (PFS) during the current systemic treatment line. The study aims to provide exploratory evidence regarding the potential value of longitudinal ctDNA monitoring for disease monitoring and prognostic assessment in patients with advanced malignant phyllodes tumors of the breast.
For a small subset of patients who become candidates for surgery or local treatment after systemic therapy, additional perioperative blood sampling may be performed before treatment, 2 to 4 weeks after surgery, and at subsequent imaging assessment time points as an exploratory analysis.
All systemic treatment decisions and routine imaging assessments will be made according to standard clinical practice. Participation in this study will not determine the choice of systemic therapy. Study ctDNA results will not replace standard clinical or imaging assessments and will not be used independently to guide treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Malignant Phyllodes Tumor Cohort | – | –Patients with advanced malignant phyllodes tumors of the breast who have distant metastases or are currently considered unsuitable for curative surgery and who are starting or receiving a current line of systemic therapy without a progression-free survival event at enrollment. Participants included in the primary longitudinal analysis must have a valid pretreatment blood sample obtained before the first dose of the current systemic treatment line. Participants will undergo longitudinal ctDNA monitoring, imaging assessment, and clinical follow-up during the current treatment line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists primarily of adult women with pathologically confirmed advanced malignant phyllodes tumors of the breast who have distant metastatic disease or are currently considered unsuitable for curative surgery. Participants will be starting or receiving a current line of systemic therapy and must not have experienced a PFS event at enrollment. The prospective main cohort will include approximately 50 participants. A small number of patients with pre-existing clinical data and archived blood samples who experienced a PFS event before formal enrollment may be included separately as retrospective exploratory cases and will not be included in the primary analyses.
Key inclusion criteria (8 listed)
- Female patients aged 18 years or older.
- Pathologically confirmed malignant phyllodes tumor of the breast.
- Distant metastatic disease, or disease considered unsuitable for curative surgery based on multidisciplinary discussion or investigator assessment.
- Planning to start the current line of systemic therapy and able to complete baseline ctDNA blood collection and the required baseline assessments before initiation of that treatment line.
- At least one lesion available for imaging follow-up and assessment of disease progression.
Key exclusion criteria (7 listed)
- 1.Insufficient candidate somatic variants available for individualized tracking in the clinical WES results, or molecular data that do not meet the requirements for establishment of an individualized ctDNA monitoring panel.
- Presence of another active malignancy that may affect assessment of the study endpoints, except for cured carcinoma in situ, non-melanoma skin cancer, or a prior malignancy judged by the investigator not to affect study endpoint assessment.
- Severe active infection, severe cardiac, pulmonary, hepatic, or renal dysfunction, uncontrolled systemic disease, or any other clinical condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
- Pregnant or breastfeeding women.
- Inability to understand the study, provide informed consent, or comply with follow-up because of psychiatric, cognitive, social, or other factors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival According to Early ctDNA Status Transition Patterns
Time frame: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA at pretreatment baseline and before Cycle 3. Cycle length varies by regimen (usually 28 days; sometimes 21 days or other durations).
Circulating tumor DNA (ctDNA) detection status at pretreatment baseline (T0) and before cycle 3 (T2) defines four groups: negative at both visits, negative-to-positive, positive-to-negative, and positive at both visits. Progression-free survival (PFS), measured in months, is the time from initiation of the current systemic treatment line to first radiologically confirmed disease progression or death from any cause. Censoring follows the study protocol. Comparisons include participants with valid paired results who remain event-free at T2. T2 status is applied only after collection of the T2 sample, with appropriate risk-set handling to avoid immortal time bias. PFS will be summarized across the four groups; exploratory Cox regression will estimate hazard ratios and 95% confidence intervals if the number of events permits. Otherwise, descriptive survival results will be reported.
6 secondary outcomes
Progression-Free Survival According to Baseline ctDNA Detection Status
Time frame: From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA status measured before the first treatment dose.
Progression-Free Survival According to Baseline ctDNA Concentration
Time frame: From initiation of the current systemic treatment line to the first radiologically confirmed disease progression, death from any cause, or censoring, assessed up to 24 months; baseline ctDNA concentration measured before the first treatment dose.
Progression-Free Survival According to ctDNA Status Transitions Before Cycle 2
Time frame: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to the ctDNA Concentration Ratio at T1 Versus Baseline
Time frame: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 2. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to the ctDNA Concentration Ratio at T2 Versus Baseline
Time frame: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA measured before the first dose and before cycle 3. Cycle length varies by regimen (usually 28 days; may be 21 days or other durations).
Progression-Free Survival According to Time-Updated ctDNA Detection Status at Subsequent Imaging Visits
Time frame: From treatment-line initiation to imaging-confirmed progression, death, or censoring (up to 24 months); ctDNA at routine CT/MRI visits following pre-cycle 3 sampling. Cycle length varies by regimen (usually 28 days; may be 21 days or other lengths).
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 29 Oct 2026.
- Background: PubMed 30860573Hrebien S, Citi V, Garcia-Murillas I, Cutts R, Fenwick K, Kozarewa I, McEwen R, Ratnayake J, Maudsley R, Carr TH, de Bruin EC, Schiavon G, Oliveira M, Turner N. Early ctDNA dynamics as a surrogate for progression-free survival in advanced breast cancer in the BEECH trial. Ann Oncol. 2019 Jun 1;30(6):945-952. doi: 10.1093/annonc/mdz085.
- Background: PubMed 39637336Bansal R, Adeyelu T, Elliott A, Tan AR, Ribeiro JR, Meisel J, Oberley MJ, Graff SL, Sledge GW Jr, Grilley-Olson JE, Sammons SL, Rosenberger LH. Genomic Landscape of Malignant Phyllodes Tumors Identifies Subsets for Targeted Therapy. JCO Precis Oncol. 2024 Dec;8:e2400289. doi: 10.1200/PO.24.00289. Epub 2024 Dec 5.
- Background: PubMed 39191445Rosenberger LH, Riedel RF, Diego EJ, Nash AL, Grilley-Olson JE, Danziger NA, Sokol ES, Ross JS, Sammons SL. Genomic landscape of malignant phyllodes tumors reveals multiple targetable opportunities. Oncologist. 2024 Dec 6;29(12):1024-1031. doi: 10.1093/oncolo/oyae218.
- Background: PubMed 38834388Mosele MF, Westphalen CB, Stenzinger A, Barlesi F, Bayle A, Bieche I, Bonastre J, Castro E, Dienstmann R, Kramer A, Czarnecka AM, Meric-Bernstam F, Michiels S, Miller R, Normanno N, Reis-Filho J, Remon J, Robson M, Rouleau E, Scarpa A, Serrano C, Mateo J, Andre F. Recommendations for the use of next-generation sequencing (NGS) for patients with advanced cancer in 2024: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2024 Jul;35(7):588-606. doi: 10.1016/j.annonc.2024.04.005. Epub 2024 May 27.
- Background: PubMed 40847758Bishr MK, Humphreys A, Ahmed M, Cox K, Hughes A, Isherwood J, Pinder SE, Remoundos DD, Sawyer E, Tamimy MS, Whisker L. Contemporary management of phyllodes tumours of the breast: recommendations from the UK Association of Breast Surgery. Br J Surg. 2025 Aug 1;112(8):znaf152. doi: 10.1093/bjs/znaf152. No abstract available.
- Background: PubMed 40702203Reason EH, Aiduk MD, Nash AL, McDuff SGR, Renner D, Kollipara RK, Satta S, Velichko S, Kalashnikova E, Rodriguez AA, Liu MC, Strickler JH, Grilley-Olson JE, Rosenberger LH. Circulating Tumor DNA (ctDNA) is Reliably Detected in Patients with Metastatic Malignant Phyllodes Tumors, a Feasibility Study. Ann Surg Oncol. 2025 Oct;32(11):8299-8308. doi: 10.1245/s10434-025-17851-3. Epub 2025 Jul 23.
- Individual participant dataSharing planned: Undecided
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.
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 Malignant Phyllodes Tumor of the Breast, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 7 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 29 Oct 2026. 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?
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 Yan Nie, PhD (+86-15876535276, nieyan7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival According to Early ctDNA Status Transition Patterns (time frame: From treatment-line initiation to radiologically confirmed progression, death, or censoring (up to 24 months); ctDNA at pretreatment baseline and before Cycle 3. Cycle length varies by regimen (usually 28 days; sometimes 21 days or other durations).). 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 NCT07903181, which also lists 6 linked publications.
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 29 Oct 2026.