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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: systemic chemotherapy Procedure: axillary lymph node dissection Procedure: neoadjuvant therapy Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Procedure: ultrasound imaging |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- False negative rate defined as number of patients with no positive lymph nodes after SLN surgery and ≥ 1 positive lymph node by axillary lymph node dissection (ALND) divided by number of patients with ≥ 1 positive lymph node by ALND [ Designated as safety issue: No ]
- Axillary ultrasound status after completion of preoperative chemotherapy (i.e., ultrasound evidence of residual lymphadenopathy versus no evidence of lymphadenopathy) [ Designated as safety issue: No ]
- Node status after preoperative chemotherapy (positive status defined as ≥ 1 positive lymph node by SLN or ALND) [ Designated as safety issue: No ]
- Extent of residual cancer burden [ Designated as safety issue: No ]
| Estimated Enrollment: | 660 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the false negative rate for sentinel lymph node (SLN) surgery in women with node-positive breast cancer.
Secondary
- To determine how the axillary ultrasound status of the patient upon completion of neoadjuvant chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination vs no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN.
- To determine how the axillary ultrasound status of the patient upon completion of neoadjuvant chemotherapy (sonographic findings) correlates with residual disease on final pathology.
- To determine the node status of patients after neoadjuvant chemotherapy.
- To determine whether the false-negative rate for SLN surgery after neoadjuvant chemotherapy is related to the extent of residual cancer burden overall, or separately in the breast or regional nodal basin.
- To evaluate pathological complete response rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival rates in node-positive patients receiving neoadjuvant chemotherapy.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant chemotherapy at the discretion of the treating physician. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy including sentinel lymph node and axillary lymph node dissection.
After completion of study treatment, patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
- Clinical stage II-IIIB (T0-4, N1-2, M0) disease, excluding inflammatory breast cancer
- Node-positive disease by fine needle aspiration or core needle biopsy of an axillary node at time of diagnosis and prior to preoperative chemotherapy
Must have completed or plan to undergo neoadjuvant chemotherapy
- 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 these studies
PATIENT CHARACTERISTICS:
- ECOG or Zubrod performance status 0-1
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph node[s]) or treatment of hidradenitis
- No prior sentinel lymph node surgery or excisional lymph node biopsy for pathological confirmation of axillary status
Contacts and Locations
Show 324 Study Locations| Study Chair: | Judy Boughey, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00881361 History of Changes |
| Other Study ID Numbers: | CDR0000640100, ACOSOG-Z1071 |
| Study First Received: | April 14, 2009 |
| Last Updated: | July 11, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013