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N/A

Surgery for Early-Stage 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
Must not have
Patients with nipple discharge
Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tbd-survivorship
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
My DCIS is 2.5 cm or smaller.
Select...
I have had or will have surgery to remove a breast cancer area with clear margins.
Select...
I have had a detailed mammogram for suspicious breast calcifications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am experiencing nipple discharge.
Select...
I have had cancer before, but it was not skin cancer or early-stage cervical cancer.
Select...
My cancer has spread to the lymph nodes in my armpit.
Select...
I have received chemotherapy or Tamoxifen as a follow-up treatment.
Select...
I have had breast cancer or DCIS in either breast before.
Select...
My cancer is invasive, possibly even at an early stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tbd-survivorship
This trial's timeline: 3 weeks for screening, Varies for treatment, and tbd-survivorship for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine if patients with DCIS can be effectively treated with wide excision alone.
Secondary study objectives
Breast

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408
98%
White blood cell decreased
96%
Platelet count decreased
94%
Neutrophil count decreased
91%
Anemia
73%
Aspartate aminotransferase increased
71%
Alanine aminotransferase increased
59%
Blood bilirubin increased
55%
Febrile neutropenia
46%
Alkaline phosphatase increased
34%
Hypomagnesemia
26%
Creatinine increased
23%
Lymphocyte count decreased
12%
Lung infection
12%
Hypermagnesemia
8%
Sepsis
8%
Hypokalemia
7%
Hypophosphatemia
6%
Dyspnea
6%
Rash maculo-papular
5%
Fatigue
5%
Hypoxia
5%
Infections and infestations - Other
5%
Hypotension
5%
Hypocalcemia
4%
Acute kidney injury
4%
Catheter related infection
4%
Hyponatremia
4%
Anorexia
4%
Diarrhea
3%
Hypertension
3%
Hyperglycemia
3%
Generalized muscle weakness
3%
Hypoalbuminemia
3%
Respiratory failure
3%
Urinary tract infection
2%
Atrial fibrillation
2%
Enterocolitis infectious
2%
Epistaxis
2%
Nausea
1%
Acidosis
1%
Skin infection
1%
Soft tissue infection
1%
Multi-organ failure
1%
Confusion
1%
Pruritus
1%
Enterocolitis
1%
Non-cardiac chest pain
1%
Cardiac disorders - Other, specify
1%
Rectal hemorrhage
1%
Edema limbs
1%
Intracranial hemorrhage
1%
Investigations - Other, specify
1%
Heart failure
1%
Sinus tachycardia
1%
Supraventricular tachycardia
1%
Colitis
1%
Vomiting
1%
Upper respiratory infection
1%
Weight loss
1%
Bone pain
1%
Pain in extremity
1%
Headache
1%
Hiccups
1%
Pulmonary edema
1%
Adult respiratory distress syndrome
1%
Left ventricular systolic dysfunction
1%
Sinusitis
1%
Blood and lymphatic disorders - Other
1%
Dehydration
1%
Tumor lysis syndrome
1%
Stroke
1%
Syncope
1%
Vasovagal reaction
1%
Abdominal pain
1%
Thromboembolic event
1%
Mucositis oral
1%
Lower gastrointestinal hemorrhage
1%
Typhlitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Induction: Clofarabine)
Arm F (Maintenance: Decitabine)
Arm A (Induction: Daunorubicin + Cytarabine)
Arm C (Consolidation: Cytarabine)
Arm D (Consolidation: Clofarabine)
Arm E (Maintenance: Observation)
Arm G (Transplant)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,113 Previous Clinical Trials
358,723 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,108 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,662 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
861 Previous Clinical Trials
12,932,668 Total Patients Enrolled
Julia Wong, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
432 Total Patients Enrolled

Media Library

Wide Excision (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT00165256 — Phase 2
Breast cancer Research Study Groups: Observation (omission of RT)
Breast cancer Clinical Trial 2023: Wide Excision Highlights & Side Effects. Trial Name: NCT00165256 — Phase 2
Wide Excision (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00165256 — Phase 2
~5 spots leftby Dec 2025
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