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History of Changes for Study: NCT01901094
Lymph Node Dissection and Radiation Therapy in Treating Patients With Breast Cancer Previously Treated With Chemotherapy and Surgery
Latest version (submitted August 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 15, 2013 None (earliest Version on record)
2 July 18, 2013 Arms and Interventions and Study Status
3 September 16, 2013 Study Status and Oversight
4 March 13, 2014 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Description
5 June 25, 2014 Contacts/Locations, Study Description, Study Status, Eligibility, Arms and Interventions and Study Identification
6 November 4, 2014 Contacts/Locations, Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Description and Study Identification
7 November 5, 2014 Arms and Interventions, Study Description, Eligibility, Outcome Measures, Conditions and Study Status
8 November 6, 2014 Outcome Measures and Study Status
9 August 27, 2015 Contacts/Locations, Arms and Interventions and Study Status
10 May 4, 2016 Study Status, Contacts/Locations and Eligibility
11 July 27, 2016 Contacts/Locations and Study Status
12 September 15, 2016 Contacts/Locations and Study Status
13 November 16, 2016 Contacts/Locations and Study Status
14 January 24, 2017 Contacts/Locations and Study Status
15 March 6, 2017 Contacts/Locations and Study Status
16 April 19, 2017 Contacts/Locations and Study Status
17 May 24, 2017 Contacts/Locations and Study Status
18 June 20, 2017 Contacts/Locations and Study Status
19 August 15, 2017 Contacts/Locations and Study Status
20 September 29, 2017 Contacts/Locations and Study Status
21 January 12, 2018 Contacts/Locations and Study Status
22 February 5, 2018 Contacts/Locations and Study Status
23 March 6, 2018 Contacts/Locations and Study Status
24 April 6, 2018 Contacts/Locations and Study Status
25 May 4, 2018 Contacts/Locations and Study Status
26 June 8, 2018 Contacts/Locations and Study Status
27 July 16, 2018 Contacts/Locations and Study Status
28 August 6, 2018 Contacts/Locations and Study Status
29 September 5, 2018 Contacts/Locations and Study Status
30 November 19, 2018 Contacts/Locations and Study Status
31 December 4, 2018 Study Status and Sponsor/Collaborators
32 January 22, 2019 Contacts/Locations and Study Status
33 February 19, 2019 Contacts/Locations and Study Status
34 May 14, 2019 Contacts/Locations and Study Status
35 June 18, 2019 Contacts/Locations and Study Status
36 August 2, 2019 Contacts/Locations and Study Status
37 September 18, 2019 Contacts/Locations and Study Status
38 October 21, 2019 Contacts/Locations and Study Status
39 October 22, 2019 Recruitment Status, Study Status and Contacts/Locations
40 November 19, 2019 Contacts/Locations and Study Status
41 January 7, 2020 Study Status and Contacts/Locations
42 February 4, 2020 Study Status and Contacts/Locations
43 March 4, 2020 Contacts/Locations and Study Status
44 April 9, 2020 Contacts/Locations and Study Status
45 May 6, 2020 Contacts/Locations and Study Status
46 May 15, 2020 Recruitment Status, Study Status, Contacts/Locations, Study Description, Eligibility and Study Design
47 June 3, 2020 Contacts/Locations and Study Status
48 July 22, 2020 Contacts/Locations and Study Status
49 September 3, 2020 Contacts/Locations and Study Status
50 October 8, 2020 Contacts/Locations and Study Status
51 November 10, 2020 Contacts/Locations and Study Status
52 December 8, 2020 Contacts/Locations and Study Status
53 January 8, 2021 Contacts/Locations and Study Status
54 February 5, 2021 Contacts/Locations and Study Status
55 March 5, 2021 Contacts/Locations and Study Status
56 April 16, 2021 Contacts/Locations, Study Status and Eligibility
57 June 9, 2021 Contacts/Locations and Study Status
58 October 11, 2021 Contacts/Locations and Study Status
59 November 11, 2021 Contacts/Locations and Study Status
60 December 13, 2021 Contacts/Locations and Study Status
61 January 11, 2022 Contacts/Locations and Study Status
62 February 16, 2022 Contacts/Locations and Study Status
63 March 22, 2022 Contacts/Locations and Study Status
64 April 18, 2022 Study Status and Contacts/Locations
65 June 3, 2022 Contacts/Locations and Study Status
66 August 2, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01901094
Submitted Date:  July 15, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: A011202
Brief Title: Lymph Node Dissection and Radiation Therapy in Treating Patients With Breast Cancer Previously Treated With Chemotherapy and Surgery
Official Title: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Secondary IDs: U10CA031946 [U.S. NIH Grant/Contract]
NCI-2013-00875 [Registry Identifier: Clinical Trial Reporting Program]
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Not yet recruiting
Study Start: July 2013
Primary Completion: January 2024 [Anticipated]
Study Completion:
First Submitted: July 12, 2013
First Submitted that
Met QC Criteria:
July 15, 2013
First Posted: July 17, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 15, 2013
Last Update Posted: July 17, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Alliance for Clinical Trials in Oncology
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known if radiation therapy alone is as effective as lymph node dissection and radiation therapy together.
Detailed Description:

All patients will undergo surgery to identify sentinel lymph node(s). If a sentinel lymph node is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph is found to be negative intra-operatively and have not undergone ALND, but had at least one sentinel lymph node found to be positive on final pathology review will be registered/randomized post-operatively.

Primary Objective:

  • To evaluate whether axillary radiation alone is not inferior to axillary radiation and ALND in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.

Secondary Objectives:

  • To evaluate whether axillary radiation alone is not inferior to axillary radiation and ALND on the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
  • To obtain an estimate of the distribution of residual disease burden scores.
  • To estimate the distribution of overall survival.

After completion of study treatment, patients are followed up for 5 years after completion of radiation therapy.

Open or close this module Conditions
Conditions: Lymphedema
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 2918 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ALND, Radiation Therapy
Patients undergo axillary lymph node dissection. Beginning 3-12 weeks following surgery, patients undergo 3D-CRT or IMRT 5 days a week for 5-6 weeks.
Procedure: Axillary Lymph Node Dissection
For patients randomized to ALND, it is recommended that a complete level I and II dissection with resection of minimum of a total of 8 lymph nodes (SLN and ALND together) are performed.
Radiation: Radiation Therapy: 3-Dimensional Conformal Radiation Therapy or Intensity-modulated radiation therapy

Post lumpectomy breast + boost:

Breast: 50 Gy in 2 Gy daily (5 days a week) fractions over 5-6 weeks. Lumpectomy cavity boost: 10 - 14 Gy in 2 Gy daily (5 days a week) fractions over 1-2 weeks to total tumor bed dose of 60-64 Gy.

Post mastectomy radiation:

Chest wall, undissected axilla, supraclavicular nodes, and internal mammary nodes:

50 Gy in 2 Gy daily fractions over 5-6 weeks. Boost: Boost to the chest wall/scar of 10 - 14 Gy in 2 Gy fractions is required on all post mastectomy patients.

Regional Nodal Irradiation:

Undissected axilla, supraclavicular nodes, and internal mammary nodes: 46 - 50 Gy in 2 Gy daily fractions over 5-6 weeks.

Other Names:
  • 3D-CRT or IMRT
Experimental: Radiation Therapy
Patients undergo 3D CRT or IMRT 5 days a week for 5-6 weeks.
Radiation: Radiation Therapy: 3-Dimensional Conformal Radiation Therapy or Intensity-modulated radiation therapy

Post lumpectomy breast + boost:

Breast: 50 Gy in 2 Gy daily (5 days a week) fractions over 5-6 weeks. Lumpectomy cavity boost: 10 - 14 Gy in 2 Gy daily (5 days a week) fractions over 1-2 weeks to total tumor bed dose of 60-64 Gy.

Post mastectomy radiation:

Chest wall, undissected axilla, supraclavicular nodes, and internal mammary nodes:

50 Gy in 2 Gy daily fractions over 5-6 weeks. Boost: Boost to the chest wall/scar of 10 - 14 Gy in 2 Gy fractions is required on all post mastectomy patients.

Regional Nodal Irradiation:

Undissected axilla, supraclavicular nodes, and internal mammary nodes: 46 - 50 Gy in 2 Gy daily fractions over 5-6 weeks.

Other Names:
  • 3D-CRT or IMRT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Invasive breast cancer recurrence-free interval (IBC-RFI)
[ Time Frame: Time from randomization to the first of the following events: invasive ipsilateral, local, regional, or distant recurrence and death due to breast cancer or treatment, assessed up to 5 years after completion of radiation therapy ]

Secondary Outcome Measures:
1. Overall survival
[ Time Frame: Up to 5 years after completion of radiation therapy ]

2. Ipsilateral/local/regional invasive breast cancer recurrence (ILR-REC)
[ Time Frame: Up to 5 years after completion of radiation therapy ]

3. Development of arm lymphedema, defined as a 10 % increase in the volume of her ipsilateral arm from its pre-surgery volume using the Breast Lymphedema Symptom Survey
[ Time Frame: Up to 2 years post surgery ]

4. Development of breast lymphedema (in BCT patients) using the Breast Lymphedema Symptom Survey
[ Time Frame: Up to 2 years post surgery ]

5. Radiation dose delivered to supraclavicular and axillary nodes
[ Time Frame: Up to 6 weeks post surgery ]

6. Residual cancer burden (RCB)
[ Time Frame: Up to 6 weeks prior to radiation therapy ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Pre-Registration Eligibility Criteria:

  • Patients 18 years of age or older.
  • Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition.
  • No inflammatory breast cancer.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible to participate.
  • All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to neoadjuvant chemotherapy.
  • Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy.
  • Patients must have completed all planned chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Patients must have completed at least 6 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes.
  • Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an institutional review board (IRB)-approved clinical trial.
  • All patients must have a clinically negative axilla (no palpable lymph nodes or bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.
  • No neoadjuvant endocrine therapy.
  • No neoadjuvant radiation therapy.
  • No sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy.
  • No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed.
  • No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease; LCIS or DCIS of contralateral breast is allowed.
  • Patients must not be pregnant or nursing. A negative pregnancy test is required prior to registration for women of childbearing potential. Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1.
  • Serum or urine beta-human chorionic gonadotropin (ß-HCG) negative in women of child-bearing potential.

Intra-Operative Registration/Randomization Criteria:

  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • A minimum of 2 or a maximum of 6 sentinel nodes are identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to Registration/Randomization.
  • At least one sentinel lymph node with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+). Axillary lymph node dissection [ALND] is not to be performed prior to Registration/Randomization.

Post-Operative Registration/Randomization Criteria:

  • For cases where ALND has not been performed and one of the following is true:
    1. intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive SLN with metastasis greater than 0.2 mm on hematoxylin and eosin stain (H & E) OR
    2. sentinel lymph node on intra-operative evaluation considered negative was found to be positive on final pathology (with metastasis greater than 0.2 mm on H & E).
  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • At least one lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining on final pathology (for cases where intra-operative evaluation was not performed, or was negative and completion dissection was not performed).
  • Among the minimum of 2 and the maximum of 6 sentinel nodes identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).
  • For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization.
Open or close this module Contacts/Locations
Study Officials: Judy Boughey, M.D.
Study Chair
Mayo Clinic
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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