Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:3/27/2019
Start Date:May 30, 2018
End Date:December 30, 2027
Contact:Wendy Parulekar
Email:wparulekar@ctg.queensu.ca
Phone:613-533-6430

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TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

The purpose of this study is to compare the effects on low risk breast cancer receiving usual
care that includes regional radiation therapy, with receiving no regional radiation therapy.
Researchers want to see if not giving this type of radiation treatment works as well at
preventing breast cancer from coming back.

Women with node positive breast cancer normally will receive endocrine therapy and some may
receive chemotherapy to help prevent the cancer from coming back. Many women will also
receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called
regional radiotherapy). No one really knows whether patients with low risk breast cancer need
to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not
need it. These women may be exposed to the side effects of their treatment without benefit.

Inclusion Criteria:

- Patients must have newly diagnosed histologically proven invasive carcinoma of the
breast with no evidence of metastases.

- Patients must have been treated by BCS or mastectomy.

- Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive
axillary nodes (macrometastases, > 2 mm).

- Patients treated by BCS and SLNB alone must have only 1-2 positive axillary nodes
(macrometastases, > 2 mm).

- Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node
(macrometastases, > 2 mm).

- Patients must be ER ≥ 1% and HER2 negative on local testing

- Patients must have an Oncotype DX recurrence score <18

- Patient must consent to provision of, and investigator(s) must confirm access to and
agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed
paraffin block of tumour tissue in order that the specific correlative marker assays
described in the protocol may be conducted

- Patient must consent to provision of samples of blood in order that the specific
correlative marker assays described in the protocol may be conducted.

- Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Endocrine
therapy can be given concurrently or following RT.

- Patients may or may not have had adjuvant chemotherapy.

- RT must be administered within 12 weeks of definitive surgery if the patient is not
treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 2-8
weeks after the last dose.

- Patient's ECOG performance status must be 0, 1 or 2.

- Patient's age must be ≥ 40 years.

- Patient's life expectancy is ≥10 years

- For the first 736 eligible English or French-speaking subjects who have agreed to
optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and
willing to complete the quality of life, health utilities and lost productivity
questionnaires in either English or French

- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements

- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of
patient randomization.

- Women of childbearing potential must have agreed to use an effective contraceptive
method. A woman is considered to be of "childbearing potential" if she has had menses
at any time in the preceding 12 consecutive months.

Exclusion Criteria:

- Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and ≤ 2 mm) or
isolated tumour cells (pN0i+ < 0.2 mm).

- Any prior history, not including the index cancer, of ipsilateral invasive breast
cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous
or previous ipsilateral LCIS are eligible.)

- Synchronous or previous contralateral invasive breast cancer. (Patients with
contralateral DCIS not treated with radiation are eligible.)

- History of non-breast malignancies except adequately treated non-melanoma skin
cancers, in situ cancers treated by local excision or other cancers curatively treated
with no evidence of disease for ≥ 5 years.

- Patients with pT3 or pT4 disease.

- Patients who are pregnant.

- Patients that have had prior ipsilateral chestwall/thoracic radiation.

- Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer.

- Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.)
which would preclude RT.

- Patients with any serious active or co-morbid medical conditions, laboratory
abnormality, psychiatric illness, active or uncontrolled infections, or serious
illnesses or medical conditions that would prevent the patient from participating or
to be managed according to the protocol (according to investigator's decision).
We found this trial at
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Pembroke Pines, Florida 33028
Principal Investigator: Ignacio Castellon
Phone: 954-265-4325
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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529 West Markham Street
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(501) 686-7000
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4502 Medical Drive
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(210) 567-7000
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Phone: 210-450-3800
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4650 Jefferson Lane Northeast
Albuquerque, New Mexico 87109
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Albuquerque, New Mexico 87109
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Annapolis, Maryland 21401
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Antigo, Wisconsin 54409
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Bemidji, Minnesota 56601
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Berkeley, California 94704
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300 N. Seventh St.
Bismarck, North Dakota 58501
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Brewer, Maine 04412
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Bronx, New York 10461
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Bronx, New York 10467
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Burlington, Massachusetts 01805
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Calgary, Alberta
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
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211 Saint Francis Drive
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573-331-3000
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, Illinois 60630
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Phone: 773-296-5360
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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6001 E Woodmen Rd
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(719) 776-5000
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3100 Plaza Properties Blvd
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(614) 383-6000
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Columbus, Ohio 43210
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2300 N Edward St
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Dover, New Hampshire 03820
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Edgewood, Kentucky 41017
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Fishersville, Virginia 22939
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1600 S Andrews Ave
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(954) 355-4400
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100 Michigan St NE
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1801 16th St
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Greenville, South Carolina 29605
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Greenville, South Carolina 29607
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Greenville, South Carolina 29615
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Greer, South Carolina 29650
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Hamilton, New Jersey 08690
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Hollywood, Florida 33021
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Indianapolis, Indiana 46202
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1400 North Ritter Avenue
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Indianapolis, Indiana 46227
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Indianapolis, Indiana 46256
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535 Barnhill Dr
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(888) 600-4822
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Jefferson Hills, Pennsylvania 15025
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Lake Forest, Illinois 60045
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Las Cruces, New Mexico 88011
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2000 N Boise Ave
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600 Highland Ave
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Memphis, Tennessee 38120
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Muncie, Indiana 47303
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Muskegon, Michigan 49444
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Oakland, California 94611
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Emile St
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(402) 559-4000
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Peoria, Illinois 61637
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15206
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Rancho Cordova, California 95670
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Rohnert Park, California 94928
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Roseville, California 95678
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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2000 Circle of Hope Dr
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(801) 585-0303
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700 Lawrence Expy
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Savannah, Georgia 31405
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Seneca, South Carolina 29672
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
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Sanford USD Medical Center - Sioux Falls Sanford
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Somerville, New Jersey 08876
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South Jordan, Utah 84095
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South San Francisco, California 94080
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7601 Southcrest Parkway
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Spartanburg, South Carolina 29307
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101 Nicolls Rd
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(631) 444-4000
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105 Sixth St
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(231) 935-5000
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929 N St Francis St
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5900 Byron Center Ave SW
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(616) 252-7200
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Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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