NCT03723928ClinicalTrials.gov

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans…

تدخّليةمطلوب 739 مشاركاً723 موقعاً3 دول

الفئات

علم الأورام88%الغدد الصمّاء والأيض12%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT03723928فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 43 days after the recorded start)First posted 2018-10-30; recorded start 2018-09-17
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 72 other studies in this databaseCounted from the lead sponsor named in the record (SWOG Cancer Research Network)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 6 conditions.
Lead sponsor type recorded as: research network.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 723 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 739 participants (target), run at 723 sites, across 3 countries.

How this score is built

Enrolment28/40
739 participants (target)
Site count25/25
723 sites
Country count7/15
3 countries
Planned duration10/10
Planned over about 222 months
Sponsor scale7/10
SWOG Cancer Research Network has led 72 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

PRIMARY OBJECTIVES: I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care. SECONDARY OBJECTIVES: I. To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population. II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population. TERTIARY OBJECTIVES: I. To assess modality and frequency of disease monitoring testing in the usual care cohort. II. To assess the association of PROs and patient preferences for disease monitoring testing. III. To evaluate predictors of physician preferences for disease monitoring testing. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

الحالات

Anatomic Stage IV Breast Cancer AJCC v8
Estrogen Receptor Positive
HER2/Neu Negative
Progesterone Receptor Positive
Prognostic Stage IV Breast Cancer AJCC v8
Elevated CA15-3 or CEA or CA27-29

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

Inclusion Criteria: * STEP 1 REGISTRATION * Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \[ER+\] and/or progesterone receptor positive \[PR+\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy). * NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic * Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease * Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease: * CEA (must be tested) * CA 15-3 or CA 27.29 (at least one of these must be tested) * At least one of the tested STMs must have been \>= 1.5 x the institutional upper limit of normal at this time. Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring. * Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician. * Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion * Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility. * Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels * Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response * Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule * Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments * Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging * Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions: * Adequately treated basal (or squamous cell) skin cancer * Any cancer from which the patient has been disease free for five years * Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins * Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy. * Patients must have decision making capacity and be able to provide informed consent * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation. * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * STEP 2 RANDOMIZATION * Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease: * CEA (must be tested) * CA 15-3 or CA 27.29 (whichever was tested prior to Step 1) Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring. * At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \>= 10% at this time. * Patients must not have known progression since registration to step 1 * Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization * Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	غير منطبق
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	HEALTH_SERVICES_RESEARCH
التعمية	NONE (0)
التجنيد	مطلوب 739 مشاركاً

الجهة الراعية والمتعاونون

SWOG Cancer Research Network الجهة الراعية
National Cancer Institute (NCI) المتعاونون

الأذرع والتدخلات

Arm I (usual care)ACTIVE_COMPARATOR
Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
Arm II (serum tumor directed disease monitoring)EXPERIMENTAL
Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

التدخلات

أخرى Anxiety Questionnaire Administration
Ancillary studies
أخرى Quality-of-Life Assessment
Ancillary studies
أخرى Serum Tumor Marker directed disease monitoring
Serum tumor markers every 4-8 weeks without imaging
أخرى Usual care disease monitoring
Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).

مقاييس النتائج

مقياس النتيجة الأولي
Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care
The assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care will be based on multivariable Cox regression, adjusting for intervention assignment (intention-to-treat) and the stratification factor (bone only versus visceral disease). If at the time of final analysis the study shows notably fewer events than anticipated, extended follow-up will be examined for its potential to allow examination of the primary endpoint with full power.
الإطار الزمني Up to 312 weeks after randomization
مقياس النتيجة الثانوي
Cumulative direct healthcare costs (in the United States) of patients monitored with STMDDM versus usual care
The comparison of direct healthcare costs (in the US) by arm will be based on a multivariable linear regression, adjusting for patient and tumor characteristics.
الإطار الزمني Up to 48 weeks after randomization
مقياس النتيجة الثانوي
Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care
Patient anxiety will be measured at baseline and at 12, 24, 36, 48, and 102 after randomization using the State-Trait Anxiety inventory Scale (STAI-S). Differences in anxiety by arm will be evaluated using a mixed-effects model for repeated measures controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.
الإطار الزمني Up to 102 weeks after randomization
مقياس النتيجة الثانوي
Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care
Patient quality of life (QOL) will be measured at baseline and at weeks 12, 24, 36, 48, and 102 after randomization using the PROMIS-29. Differences in QOL by arm will be evaluated using a mixed-effects model for repeated measures, controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.
الإطار الزمني Up to 102 weeks after randomization

التواريخ

التواريخ
تاريخ البدء	17 سبتمبر 2018 (فعلي)
الإتمام الأولي	1 ديسمبر 2030 (تقديري)
الإتمام	1 ديسمبر 2036 (تقديري)
أول نشر	30 أكتوبر 2018 (فعلي)
آخر تحديث	2 أبريل 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	أبريل 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

592 موقعاً قيد التجنيد

Guam

Guam
المنشأة	المدينة	الولاية أو المنطقة	الحالة
FHP Health Center-Guam	Tamuning		مُعلَّق

Puerto Rico

Puerto Rico
المنشأة	المدينة	الحالة
Advance Oncology Center	Aguadilla	مُعلَّق
Doctor's Cancer Center-Arecibo	Arecibo	مُعلَّق
Hematologia Oncologia San Pablo	Bayamón	مُعلَّق
Cancer Center-Metro Medical Center Bayamon	Bayamón	قيد التجنيد
HIMA San Pablo Oncologic Hospital	Caguas	مُعلَّق
Doctors Cancer Center	Manati	قيد التجنيد
Instituto Oncologia Moderna Ponce	Ponce	مُعلَّق
Centro Comprensivo de Cancer de UPR	San Juan	قيد التجنيد
San Juan Community Oncology Group	San Juan	قيد التجنيد
San Juan City Hospital	San Juan	قيد التجنيد
PROncology	San Juan	قيد التجنيد
Primary Care Physician Group	San Juan	مُعلَّق
Centro de Hematologia y Oncologia del Sur	Santa Isabel	مُعلَّق

United States

United States
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	قيد التجنيد
Hickman Cancer Center	Adrian	Michigan	قيد التجنيد
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	قيد التجنيد
University of New Mexico Cancer Center	Albuquerque	New Mexico	قيد التجنيد
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	قيد التجنيد
Saint Anthony's Health	Alton	Illinois	قيد التجنيد
American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	مُعلَّق
McFarland Clinic - Ames	Ames	Iowa	قيد التجنيد
Mary Greeley Medical Center	Ames	Iowa	قيد التجنيد
Community Hospital of Anaconda	Anaconda	Montana	قيد التجنيد
Kaiser Permanente-Anaheim	Anaheim	California	قيد التجنيد
Providence Alaska Medical Center	Anchorage	Alaska	قيد التجنيد
Katmai Oncology Group	Anchorage	Alaska	قيد التجنيد
Anchorage Oncology Centre	Anchorage	Alaska	قيد التجنيد
Alaska Women's Cancer Care	Anchorage	Alaska	قيد التجنيد
Anchorage Associates in Radiation Medicine	Anchorage	Alaska	قيد التجنيد
Alaska Oncology and Hematology LLC	Anchorage	Alaska	قيد التجنيد
Anchorage Radiation Therapy Center	Anchorage	Alaska	قيد التجنيد
Alaska Breast Care and Surgery LLC	Anchorage	Alaska	قيد التجنيد
Saint Joseph Mercy Hospital	Ann Arbor	Michigan	قيد التجنيد
Langlade Hospital and Cancer Center	Antigo	Wisconsin	قيد التجنيد
PCR Oncology	Arroyo Grande	California	قيد التجنيد
Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	قيد التجنيد
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	قيد التجنيد
Emory University Hospital Midtown	Atlanta	Georgia	قيد التجنيد
Emory Saint Joseph's Hospital	Atlanta	Georgia	قيد التجنيد
Grady Health System	Atlanta	Georgia	قيد التجنيد
MultiCare Auburn Medical Center	Auburn	Washington	مُعلَّق
Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	قيد التجنيد
Rush - Copley Medical Center	Aurora	Illinois	قيد التجنيد
The Medical Center of Aurora	Aurora	Colorado	مُعلَّق
Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	قيد التجنيد
Saint Alphonsus Medical Center-Baker City	Baker City	Oregon	قيد التجنيد
Kaiser Permanente-Baldwin Park	Baldwin Park	California	قيد التجنيد
Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri	قيد التجنيد
Flaget Memorial Hospital	Bardstown	Kentucky	قيد التجنيد

يُدرَج 673 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03723928