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Observation for Breast Cancer
Phase 2
Waitlist Available
Led By Julia Wong, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The clinical extent of DCIS must be less than or equal to 2.5 cm
Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tbd-survivorship
Awards & highlights
Study Summary
This trial will help determine if surgery to remove the cancer is the only treatment needed for small, early-stage breast cancers.
Who is the study for?
This trial is for individuals with small, low-grade ductal carcinoma in situ (DCIS) of the breast, measuring less than or equal to 2.5 cm. Participants must have had a recent high-quality mammogram and undergone surgical removal with clear margins of at least 1 cm. They should not have invasive cancer, previous breast cancers, nipple discharge, or be on certain cancer treatments like chemotherapy.Check my eligibility
What is being tested?
The study is testing if just surgically removing the affected tissue—wide excision—is enough treatment for grade 1 or 2 DCIS without additional therapies. The effectiveness will be observed over time after surgery to ensure all suspicious areas are removed.See study design
What are the potential side effects?
Since this trial involves observation after surgery rather than drug intervention, side effects may include typical post-surgical complications such as pain at the incision site, infection risk, scarring and potential psychological impacts from monitoring without further immediate treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My DCIS is 2.5 cm or smaller.
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I have had or will have surgery to remove a breast cancer area with clear margins.
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I have had a detailed mammogram for suspicious breast calcifications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tbd-survivorship
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tbd-survivorship
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if patients with DCIS can be effectively treated with wide excision alone.
Secondary outcome measures
Breast
Side effects data
From 2016 Phase 3 trial • 356 Patients • NCT0004899731%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Mood alteration-depression
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Observation (omission of RT)Experimental Treatment1 Intervention
Wide excision of DCIS; no radiotherapy (RT).
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,714 Total Patients Enrolled
142 Trials studying Breast Cancer
22,617 Patients Enrolled for Breast Cancer
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,719 Total Patients Enrolled
47 Trials studying Breast Cancer
109,739 Patients Enrolled for Breast Cancer
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,178 Total Patients Enrolled
48 Trials studying Breast Cancer
7,265 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was not skin cancer or early-stage cervical cancer.My cancer has spread to the lymph nodes in my armpit.My breast cancer is at an early stage (Grade 1 or 2) and may also have LCIS.My DCIS is 2.5 cm or smaller.I have had or will have surgery to remove a breast cancer area with clear margins.I have received chemotherapy or Tamoxifen as a follow-up treatment.I have had a radiograph to confirm the removal of all suspicious areas in my breast.I have had breast cancer or DCIS in either breast before.My cancer is invasive, possibly even at an early stage.I am experiencing nipple discharge.I have had a detailed mammogram for suspicious breast calcifications.I had my last surgery less than 3 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Observation (omission of RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollments for this research study?
"Sadly, current records on clinicaltrials.gov declare that this trial has ceased enrolling new patients, as the last update was made 11/1/2022. Nonetheless, there are over 2500 other trials seeking participants at present."
Answered by AI
Has the FDA formally endorsed Observation as an approved treatment?
"Our team has assigned observation a safety score of 2, since it is in Phase 2 with evidence showing its relative safety but no data supporting the efficacy."
Answered by AI
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