NCT05929768ClinicalTrials.gov
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
בקצרה
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from…
שלב 3דרושים 2,400 משתתפים963 אתרים3 מדינות
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT05929768פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
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.
- Present: Registered before enrolment beganFirst posted 2023-07-03; recorded start 2023-09-15
- 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 5 conditions.
- Lead sponsor type recorded as: research network.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
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.
A strong methodological design for a phase 3 study, 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: 963 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 2,400 participants (target), run at 963 sites, across 3 countries.
How this score is built
- Enrolment34/40
2,400 participants (target)
- Site count25/25
963 sites
- Country count7/15
3 countries
- Planned duration10/10
Planned over about 116 months
- Sponsor scale7/10
SWOG Cancer Research Network has led 72 trials in our corpus
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.
תקציר
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
מצבים רפואיים
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Early Stage Triple-Negative Breast Carcinoma
זכאות
| מין | הכול |
|---|---|
| גילאים | 18 Years – ללא מקסימום |
| מתנדבים בריאים | לא |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 3 |
| הקצאה | אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | NONE (0) |
| גיוס | דרושים 2,400 משתתפים |
נותן חסות ושותפים
- SWOG Cancer Research Network נותן חסות
- National Cancer Institute (NCI) שותפים
זרועות והתערבויות
- Arm I (usual chemo-immunotherapy)ACTIVE_COMPARATOR
Patients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
- Arm II (shorter chemo-immunotherapy)EXPERIMENTAL
Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
התערבויות
- פרוצדורה Biospecimen Collection
Undergo collection of blood samples
- תרופה Carboplatin
Given IV
- תרופה Cyclophosphamide
Given IV
- תרופה Docetaxel
Given IV
- תרופה Doxorubicin
Given IV
- תרופה Paclitaxel
Given IV
- ביולוגי Pembrolizumab
Given IV
- אחר Quality-of-Life Assessment
Ancillary studies
- אחר Questionnaire Administration
Ancillary studies
- פרוצדורה Surgical Procedure
Undergo surgery
מדדי תוצאה
מדד תוצאה ראשוני
Breast cancer event-free survival (BC-EFS)
Time from randomization to the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. BC-EFS will be compared between the treatment arms using Cox regression with adjustment for nodal status and sTIL enrichment.
מסגרת זמן Up to 5 years
מדד תוצאה משני
Pathologic complete response (pCR)
pCR rates by assigned treatment arm will be compared using a difference of two proportions overall and by stromal tumor infiltrating lymphocytes (sTIL) group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.
מסגרת זמן From date of randomization to date of the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause, assessed up to 5 years
מדד תוצאה משני
Residual cancer burden (RCB)
RCB 0/I rates (i.e., RCB-0 and RCB-I combined) by assigned treatment arm will be compared using a difference of two proportions overall and by sTIL group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.
מסגרת זמן Up to 5 years
מדד תוצאה משני
Distant relapse-free survival (DRFS)
DRFS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.
מסגרת זמן From date of randomization to date of invasive distant disease recurrence or death due to any cause, assessed up to 5 years
מדד תוצאה משני
Overall survival (OS)
OS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.
מסגרת זמן From date of randomization to date of death due to any cause, assessed up to 5 years
מדד תוצאה משני
Distant relapse-free interval (DRFI)
DRFI will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. Deaths not due to breast cancer will be considered competing risks in this analysis. Cumulative incidence curves will describe the two arms over the follow-up period from randomization.
מסגרת זמן From date of randomization to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
מדד תוצאה משני
Relapse free survival (RFS)
RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who had pCR. Nodal status and sTIL status will be included as covariates if there are sufficient numbers of events for the analysis. The expectation is that invasive breast cancer-free survival after pCR should not differ by treatment assignment.
מסגרת זמן From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
מדד תוצאה משני
RFS
RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who did not have a pCR. Nodal status and sTIL status will be included as covariates.
מסגרת זמן From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
מדד תוצאה משני
Incidence of adverse events
Rates of adverse events will be compared between treatment arms for those initiating the assigned therapy.
מסגרת זמן Up to 5 years
מדד תוצאה משני
Patient-Reported Fatigue
Participant-reported fatigue will be compared between treatment arms using the Participant-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a at 3 weeks after the last neoadjuvant systemic therapy dose and at 18 months after randomization. The PROMIS Fatigue-7a is a validated 7-item questionnaire that assesses participant-reported fatigue in the past 7 days. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher T-scores indicate more fatigue.
מסגרת זמן Up to 18 months
מדד תוצאה משני
Patient-Reported Physical Function
Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 3-5 weeks after the last neoadjuvant systemic therapy dose. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.
מסגרת זמן Up to 5 weeks after the last neoadjuvant systemic therapy dose
מדד תוצאה משני
Patient-Reported Physical Function
Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 18 months after randomization. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.
מסגרת זמן Up to 18 months
תאריכים
| תאריך התחלה | 15 בספטמבר 2023 (בפועל) |
|---|---|
| סיום ראשוני | 31 במרץ 2033 (משוער) |
| סיום | 1 באפריל 2033 (משוער) |
| פורסם לראשונה | 3 ביולי 2023 (בפועל) |
| עודכן לאחרונה | 5 בנובמבר 2025 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | נובמבר 2025 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
923 אתרים מגייסים
Mexico
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Instituto Nacional De Cancerologia de Mexico | Mexico City | Tlalpan | מגייס |
Puerto Rico
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Puerto Rico Hematology Oncology Group | Bayamón | מגייס | |
| Cancer Center-Metro Medical Center Bayamon | Bayamón | מגייס | |
| Doctors Cancer Center | Manati | מגייס | |
| PROncology | San Juan | מגייס | |
| San Juan Community Oncology Group | San Juan | מגייס | |
| San Juan City Hospital | San Juan | מגייס | |
| Centro Comprensivo de Cancer de UPR | San Juan | מגייס |
United States
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| UM Upper Chesapeake Hematology and Oncology - Aberdeen | Aberdeen | Maryland | מגייס |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | מגייס |
| Hickman Cancer Center | Adrian | Michigan | מושהה |
| Riverwood Healthcare Center | Aitkin | Minnesota | מגייס |
| Summa Health System - Akron Campus | Akron | Ohio | מגייס |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | מגייס |
| Aultman Alliance Community Hospital | Alliance | Ohio | מגייס |
| MyMichigan Medical Center Gratiot | Alma | Michigan | מגייס |
| MyMichigan Medical Center Alpena | Alpena | Michigan | מגייס |
| OSF Saint Anthony's Health Center | Alton | Illinois | מגייס |
| McFarland Clinic - Ames | Ames | Iowa | מגייס |
| Mary Greeley Medical Center | Ames | Iowa | מגייס |
| Community Hospital of Anaconda | Anaconda | Montana | מגייס |
| Kaiser Permanente-Anaheim | Anaheim | California | מגייס |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | מגייס |
| Katmai Oncology Group | Anchorage | Alaska | מגייס |
| Providence Alaska Medical Center | Anchorage | Alaska | מגייס |
| Anchorage Oncology Centre | Anchorage | Alaska | מושהה |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | מושהה |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | מגייס |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | מגייס |
| Alaska Women's Cancer Care | Anchorage | Alaska | מגייס |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | מגייס |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | מגייס |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | מגייס |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | פעיל, ללא גיוס |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | מגייס |
| Ascension Saint Elizabeth Hospital | Appleton | Wisconsin | מגייס |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | מגייס |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | מגייס |
| PCR Oncology | Arroyo Grande | California | מגייס |
| Cone Health MedCenter Asheboro | Asheboro | North Carolina | מגייס |
| Cone Health Cancer Center at Asheboro | Asheboro | North Carolina | מושהה |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | מגייס |
| Duluth Clinic Ashland | Ashland | Wisconsin | מגייס |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | מגייס |
| Grady Health System | Atlanta | Georgia | מגייס |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | מגייס |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | מגייס |
| Emory University Hospital Midtown | Atlanta | Georgia | מגייס |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | מגייס |
| Sutter Auburn Faith Hospital | Auburn | California | מגייס |
913 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.
שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.