Know Cancer

forgot password

A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer



- Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in
women with radically resected loco-regional relapsed breast cancer.


- Determine the systemic disease-free and overall survival of patients treated with this

- Determine the sites of recurrence, incidence of second (non-breast) malignancies, and
causes of death without relapse of breast cancer in patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen (QOL portion closed

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR)
positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs
regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive radiotherapy* within 6 months after surgery.

- Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an
adjuvant chemotherapy regimen as determined by the investigator. Patients also receive
radiotherapy* within 6 months after surgery and after the completion of chemotherapy OR
integrated with chemotherapy.

NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not
required to receive further radiotherapy

Patients with ER and/or PR positive tumors also receive standard hormonal therapy.

Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically confirmed invasive breast cancer

- First local and/or regional (i.e., ipsilateral axillary or internal mammary
lymph node region) recurrence after primary treatment with mastectomy or
lumpectomy/quadrantectomy with clear surgical margins

- Local failure is defined as a tumor recurrence in any soft tissue of the
ipsilateral conserved breast or the chest wall, mastectomy scar, and/or

- Regional failure is defined as a tumor recurrence in the ipsilateral
axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla,
and/or ipsilateral internal mammary. Regional failure does not include
supraclavicular lymph nodes or tumor in the opposite breast

- No other prior recurrence in any site, including local

- Surgical resection of the recurrence meeting 1 of the following criteria:

- Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for
patients who had no prior adjuvant radiotherapy

- Mastectomy of the recurrence with uninvolved ("clear") margins after
lumpectomy/quadrantectomy alone for the primary

- Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are
allowed for patients with HER-2 positive tumors and must be declared prior to

- No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes,
by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or
bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically
indicated (e.g., bone pain)

- No macroscopically incomplete surgery

- No bilateral malignancy except carcinoma in situ

- No suspicious mass in the opposite breast unless that mass has been proven by biopsy
to be benign

- No skeletal pain of unknown cause

- No hot spots on bone scan for which metastases cannot be ruled out by x-ray,
MRI, and/or CT scan

- Hormone receptor status:

- Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding

- Estrogen receptor positive or negative

- Progesterone receptor positive or negative



- Any age


- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- No elevated alkaline phosphatase


- Not specified


- Fertile patients must use effective non-hormonal contraception

- Medically suitable for chemotherapy of 3-6 months duration

- No other primary malignant tumors except adequately treated carcinoma in situ of the
cervix or nonmelanoma skin cancer

- No non-malignant systemic disease that would preclude study treatment or prolong

- No psychiatric or addictive disorder that would preclude giving informed consent

- No history of noncompliance to medical regimens or potential for being unreliable


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- See Disease Characteristics


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

10 years after randomization

Safety Issue:


Principal Investigator

Stefan Aebi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Inselspital Bern, Switzerland


United States: Federal Government

Study ID:




Start Date:

July 2002

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Tufts-NEMC Cancer Center Boston, Massachusetts  02111
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
St. Rita's Medical Center Lima, Ohio  45801
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
Newark Beth Israel Medical Center Newark, New Jersey  07112
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Wesley Medical Center Wichita, Kansas  67214
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Batte Cancer Center at Northeast Medical Center Concord, North Carolina  28025
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Hope A Women's Cancer Center Asheville, North Carolina  28801
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Front Range Cancer Specialists Fort Collins, Colorado  80528
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Kaiser Permanente - Fremont Fremont, California  94538
Kaiser Permanente Medical Center - Hayward Hayward, California  94545
Kaiser Permanente Medical Center - Redwood City Redwood City, California  94063
Kaiser Permanente Medical Center - Richmond Richmond, California  94801
Kaiser Permanente Medical Center - Roseville Roseville, California  95661
South Sacramento Kaiser-Permanente Medical Center Sacramento, California  95823
Kaiser Permanente Medical Center - Santa Teresa San Jose, California  95119
Kaiser Foundation Hospital - San Rafael San Rafael, California  94903
Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Kaiser Permanente Medical Center - South San Francisco South San Francisco, California  94080
Kaiser Permanente Medical Facility - Stockton Stockton, California  95210
Kaiser Permanente Medical Center - Walnut Creek Walnut Creek, California  94596
Poudre Valley Hospital Fort Collins, Colorado  80524
Edward Hospital Cancer Center Naperville, Illinois  60540
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Genesis Medical Center - West Campus Davenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Wood County Oncology Center Bowling Green, Ohio  43402
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
Kaiser Permanente Health Care - Portland Portland, Oregon  97232
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Doctor's Hospital of Laredo Laredo, Texas  78041
Danville Regional Medical Center Danville, Virginia  24541
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Northeast Georgia Medical Center Gainesville, Georgia  30501
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
Kaiser Permanente - Deer Valley Antioch, California  94531
Stanford Cancer Center Stanford, California  94305-5824
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
North Coast Cancer Care - Clyde Clyde, Ohio  43410
Hematology Oncology Center Elyria, Ohio  44035
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Saint Michael's Hospital Cancer Center Stevens Point, Wisconsin  54481
Marshfield Clinic - Wausau Center Wausau, Wisconsin  54401
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Diagnostic and Treatment Center Weston, Wisconsin  54476
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
La Grange Memorial Hospital La Grange, Illinois  60525
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
AnMed Cancer Center Anderson, South Carolina  29621
Southeastern Medical Oncology Center - Goldsboro Goldsboro, North Carolina  27534
Kent General Hospital Dover, Delaware  19901