Breast CancerPhase 3NCT01468883

The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation

A Phase 3 study testing M and X in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: M and X
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 1 siteUnited States
Study dates: 4 Sep 1979to 17 Nov 2016
Phase: Phase 3
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol:
On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage I and II).
Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin.
Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
Patient must be mentally competent to understand and give informed consent for the protocol.

Who cannot join

Patients will be excluded from this protocol for the following reasons:
Advanced local disease or distant metastases (stage III and IV);
Inflammatory cancer;
Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk;
History of another cancer other than skin cancer (non-melanoma);
Concurrent pregnancy or lactation;

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Non-palpable lesions manifested only by nipple discharge or skin rash (Paget's disease);
Previous therapy to the breast cancer other than excisional biopsy;
Multiple masses or multiple suspicious areas on mammogram unless all but one are proven histologically benign; and
Bilateral breast carcinoma, either invasive or in-situ.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection vs. Excisional Biopsy Axillary Dissection, and Definitive Irradiation

Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.

Read the detailed description

Conditions: Breast Cancer
Being tested: M, X
Keywords: Breast Cancer, Surgery, Radiation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MProcedure or surgery
Modified radical mastectomy
XRadiation
Excisional biopsy plus radiation

Study groups in NCT01468883
Study group	Role	What they receive
M	Active comparator	Modified radical mastectomy Receives: Procedure: M
X	Experimental	Excisional biopsy plus radiation Receives: Radiation: X

What is being measured

The primary outcome is the main question the study is designed to answer.

Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
Measured: survival rate completion of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 197917 Nov 2016

First posted10 Nov 2011 (estimated)
Study start4 Sep 1979
Primary completion27 Sep 2016
Study completion17 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01468883
Sponsor's protocol ID: 790111
Other IDs: 79-C-0111
Status last verified: Apr 2024
First submitted: 1 Oct 2011
Last updated: 26 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection vs. Excisional Biopsy Axillary Dissection, and Definitive Irradiation
ClinicalTrials.gov ID: NCT01468883
Acronym / sponsor ID: 790111
Conditions: Breast Cancer
Keywords: Breast Cancer, Surgery, Radiation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 4 Sep 1979 (actual)
Primary completion: 27 Sep 2016 (actual)
Study completion: 17 Nov 2016 (actual)
First posted: 10 Nov 2011 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
M	Active comparator	Procedure: MModified radical mastectomy
X	Experimental	Radiation: XExcisional biopsy plus radiation

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol:
On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage I and II).
Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin.
Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
Patient must be mentally competent to understand and give informed consent for the protocol.

Key exclusion criteria (10 listed)

Advanced local disease or distant metastases (stage III and IV);
Inflammatory cancer;
Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk;
History of another cancer other than skin cancer (non-melanoma);
Concurrent pregnancy or lactation;

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
MModified radical mastectomy	Procedure or surgery	M
XExcisional biopsy plus radiation	Radiation	X

Primary outcome

Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
Time frame: survival rate completion of study
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy

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 26 Apr 2024.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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Lymphedema, Upper Extremity Lymphedema
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Kevin A Camphausen, M.D. principal investigator

National Cancer Institute (NCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing M and X in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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 10 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy (time frame: survival rate completion of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468883.

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 26 Apr 2024.