Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:July 2002
End Date:June 2016

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known whether chemotherapy is effective in
treating women who have undergone surgery and radiation therapy for relapsed breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy
in treating women who have undergone resection for local and/or regional relapsed breast
cancer.

OBJECTIVES:

Primary

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

Secondary

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

- 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
11/13/08).

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
11/13/08).

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.

DISEASE CHARACTERISTICS:

- 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
skin

- 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
randomization

- 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
assay

- Estrogen receptor positive or negative

- Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age

- Minimum 18 years

Sex

- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No elevated alkaline phosphatase

Renal

- Not specified

Other

- 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
follow-up

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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics
We found this trial at
167
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1200 S Cedar Crest Blvd
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1300 Morris Park Avenue
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2600 6th Street Southwest
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330-452-9911
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86 Jonathan Lucas Street
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2500 Metrohealth Dr # C2100
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100 North Academy Ave
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570-271-6211
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1 Hurley Plaza
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
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200 Hawkins Drive
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800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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1800 West Charleston Boulevard
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