Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/7/2018 |
Start Date: | July 2009 |
A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy
before surgery may make the tumor smaller and reduce the amount of normal tissue that needs
to be removed.
PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and
axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage
IIIB breast cancer.
cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy
before surgery may make the tumor smaller and reduce the amount of normal tissue that needs
to be removed.
PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and
axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage
IIIB breast cancer.
This is a multicenter study. Patients who plan to receive or have received neoadjuvant
chemotherapy are eligible. Patients undergo examination for breast and axilla lymph
adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm
eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing
neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon
discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
The primary and secondary objectives of the study are described below.
Primary Objective:
1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the
patients who have at least one sentinel lymph node identified and removed, false negative
rate is defined as the number of patients declared to have no evidence of cancer in the SLN
and are found to have at least one positive lymph node in the ALND divided by the total
number of patients with at least one positive axillary lymph node by ALND.
Secondary Objectives:
1. To determine how the axillary ultrasound status of the patient upon completion of
preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound
examination versus no evidence of lymphadenopathy in the ultrasound examination) affects
the false negative rate of SLN and how sonographic findings correlate with residual
disease on final pathology.
2. To determine the node status of patients after preoperative chemotherapy. Patients will
be classified as node positive if they were determined to have at least one positive
lymph node by SLN or ALND. Patients will be classified as node negative if all nodes
examined by SLN and ALND were negative.
3. To determine whether the false-negative rate for SLN surgery after preoperative
chemotherapy is related to the extent of residual cancer burden (RCB) overall, or
separately in the breast or regional nodal basin.
4. To evaluate pathological complete response (pCR) rates (defined as no invasive disease
in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive
patients receiving preoperative chemotherapy.
After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks
then patients are followed every 6 months for 2 years, yearly for 2 years, then every other
year for 6 years. The study closed to accrual and treatment on 5/29/12.
chemotherapy are eligible. Patients undergo examination for breast and axilla lymph
adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm
eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing
neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon
discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
The primary and secondary objectives of the study are described below.
Primary Objective:
1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the
patients who have at least one sentinel lymph node identified and removed, false negative
rate is defined as the number of patients declared to have no evidence of cancer in the SLN
and are found to have at least one positive lymph node in the ALND divided by the total
number of patients with at least one positive axillary lymph node by ALND.
Secondary Objectives:
1. To determine how the axillary ultrasound status of the patient upon completion of
preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound
examination versus no evidence of lymphadenopathy in the ultrasound examination) affects
the false negative rate of SLN and how sonographic findings correlate with residual
disease on final pathology.
2. To determine the node status of patients after preoperative chemotherapy. Patients will
be classified as node positive if they were determined to have at least one positive
lymph node by SLN or ALND. Patients will be classified as node negative if all nodes
examined by SLN and ALND were negative.
3. To determine whether the false-negative rate for SLN surgery after preoperative
chemotherapy is related to the extent of residual cancer burden (RCB) overall, or
separately in the breast or regional nodal basin.
4. To evaluate pathological complete response (pCR) rates (defined as no invasive disease
in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive
patients receiving preoperative chemotherapy.
After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks
then patients are followed every 6 months for 2 years, yearly for 2 years, then every other
year for 6 years. The study closed to accrual and treatment on 5/29/12.
Eligibility Criteria:
1. ≥ 18 years old
2. ECOG/Zubrod Performance Status 0-1
3. Female. Note: Men are excluded from this study because the number of men with breast
cancer is insufficient to provide a statistical basis for assessment of effects in
this subpopulation of people with breast cancer.
4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding
inflammatory breast cancer).
5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time
of diagnosis and prior to preoperative chemotherapy.
6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients
enrolling on studies involving preoperative chemotherapy (through cooperative groups
or institutional studies) may be eligible for this study, provided sentinel node
surgery prior to preoperative chemotherapy was not required in the other studies.
7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
treatment of hidradenitis.
8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of
axillary status.
We found this trial at
326
sites
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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(610) 402-8000
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1300 Morris Park Avenue
Bronx, New York 10461
Bronx, New York 10461
718.430.2302
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
(843) 792-0700
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
(704) 355-2884
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
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100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-8521
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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1240 S Old Dixie Hwy
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(561) 263-4400
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1900 South Avenue
La Crosse, Wisconsin 54601
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401 College Street
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601 Elmwood Avenue
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825 N Emporia Ave
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(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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1 Medical Center Blvd
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(336) 716-2011
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1 Akron General Ave
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Akron, Ohio 44307
(330) 344-6000
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1500 East Medical Center Drive
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Ann Arbor, Michigan 48109
800-865-1125
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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300 North Ave
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(269) 245-8000
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8111 South Emerson Avenue
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(317) 528-5000
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Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
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1101 N 27th St # 201
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(406) 237-3585
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2900 12th Ave N Ste 160W
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
Castro Valley, California 94546
(510) 888-0657
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101 Manning Drive
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
(919) 966-0000
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Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
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1969 W Ogden Ave
Chicago, Illinois 60612
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(312) 864-6000
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
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Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
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411 Laurel St New Visions
Des Moines, Iowa 50314
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(515) 247-3970
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Des Moines, Iowa 50314
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(515) 247-3121
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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(515) 244-7586
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Detroit, Michigan 48202
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(888) 777-4167
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