Early-Stage Breast CancerPhase 2NCT00165243
Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer
A Phase 2 study testing Tangential radiation in people with Early-Stage Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Early-Stage Breast Cancer
- What is being tested?
- Tangential radiation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
- Patients must be 55 years or older.
- Patients must undergo total excision of the primary invasive tumor
- Final pathologic margin status must be negative
- Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted
Who cannot join
- Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.
Read the detailed description
- Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
- Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
- No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
- Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
- Follow-up visits will occur every 6 months and mammograms every 12 months.
- Conditions
- Early-Stage Breast Cancer
- Being tested
- Tangential radiation
- Keywords
- Axillary Dissection, Tangential Radiation, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangential radiationProcedure or surgery
Radiation given over 6 1/2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
Measured: 5 years
Secondary outcomes (1)
To determine the safety of this treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 1998
- Primary completionJan 2004
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Julia S. Wong, MD, Dana-Farber Cancer Institute
- Investigators
- Julia S. Wong, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165243
- Sponsor's protocol ID
- 98-101
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2005
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00165243
- Acronym / sponsor ID
- 98-101
- Conditions
- Early-Stage Breast Cancer
- Keywords
- Axillary Dissection, Tangential Radiation, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Sep 1998
- Primary completion
- Jan 2004 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Sep 2005 (estimated)
- 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.
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.
Detailed description
- Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
- Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
- No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
- Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
- Follow-up visits will occur every 6 months and mammograms every 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
- Patients must be 55 years or older.
- Patients must undergo total excision of the primary invasive tumor
- Final pathologic margin status must be negative
- Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted
Key exclusion criteria (1 listed)
- Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tangential radiationRadiation given over 6 1/2 weeks | Procedure or surgery | – |
Primary outcome
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
Time frame: 5 years
1 secondary outcome
To determine the safety of this treatment.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
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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. This study is not recruiting at the moment.
Julia S. Wong, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tangential radiation in people with Early-Stage Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2017.