NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

Alliance A011202 - "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"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact KCCOP for complete protocol information.



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Breast Clinical Trial

CANCER TYPE: Stage II
RESEARCH BASE: CTSU Alliance A011202
NCT NUMBER:
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Post-Neoadj, T1-3N1M0 (prior to neoadjuv chemo); Eval of axillary LN dissection for positive sentinel LN disease.  DCP-001 Eligible



NOTES


Treatment Plan      (Supplied Drug:  N/A)

 

FOR PATIENTS WHO PRE-REGISTER PRIOR TO SLN SURGERY:

Completed at least 4 cycles of neoadj. chemo, clinically negative axilla on PE after neoadj. chemo

PRE-REGISTRATION

Followed by:

SURGERY w/SENTINEL LYMPH NODE SURGERY

Followed by:

If SLN not identified - No Registration & Randomization

If Positive SLN identified

Intra-operative Registration & Randomization

Followed by:

Arm 1:  Axillary LN Dissection* + Nodal RT** (w/o RT to dissected axilla)

Arm 2:  Axillary + Nodal RT**

If Negative SLN by Intra-Op Eval & Positive SLN(s) on Final Path & ALND not performed

Registration & Randomization

Followed by:

Arm 1:  Axillary LN Dissection* + Nodal RT** (w/o RT to dissected axilla)

Arm 2:  Axillary + Nodal RT**

If Negative SLN by Intra-Op Eval & Negative LN(s) on Final Path

No Registration, Randomization, or Follow-up (consider participation in CTSU NSABP B-51)

 

FOR PATIENTS WHO PRE-REGISTER AFTER SLN SURGERY:

  • Clinically T1-3 N1 M0 Breast cancer Axillary ultrasound with FNA or core biopsy documenting positive lymph node
  • Neoadjuvant chemotherapy completed (minimum of 4 cycles), clinically negative axilla on PE after neoadjuvant chemotherapy
  • Surgery with Sentinel Lymph Node Surgery
  • Positive Lymph Node(s) on Final Pathology and ALND not performed

PRE-REGISTRATION AND REGISTRATION / RANDOMIZATION

Arm 1:  ALND + Nodal XRT (without XRT to dissected axilla)

Arm 2:  Axillary XRT and Nodal XRT

 

*   Recommendation is a complete Level I & II dissection w/resection of minimum of 8 LNs (SLN & ALND together).

**  5 days/wk for 5-6 wks.  Begin >21 days & < 84 days following surgery.



ELIGIBILITY

PRE-REGISTRATION ELIGIBILITY

  • Age >18.
  • Clinical stage T1-3 N1 M0 breast cancer at dx (prior to start of neoadjuv chemo) by AJCC staging 7th edition.
  • No inflammatory breast cancer.
  • No other malignancy w/i 5 yrs pre-regist except non-melanoma skin cancer treated w/local resection only or cervical carcinoma in situ.
  • Axillary US w/FNA or core needle bx of axillary LNs documenting axillary mets at time of dx, prior to or <14 days after starting neoadjuv chemo.  Bx of intramammary nodes does not fulfill this criterion.
  • ER, PgR, & HER2 status (IHC &/or ISH) evaluated on diagnostic core bx prior to start of neoadjuv chemo.  If HER2 status equivocal or indeterminate, pt should not be enrolled.
  • Patients must have completed all chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Patients must have completed at least 4 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.
    Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered. More than 4 cycles of NAC may be administered at the discretion of the treating medical oncologist.
  • Pts w/HER2 positive tumors must have received neoadjuv Trastuzumab, Trastuzumab + Pertuzumab, or other approved anti-HER2 therapy (either w/all or with a portion of the neoadjuv chemo regimen).  Must be FDA-approved targeted anti-HER2 therapy, but additional therapies &/or non-Trastuzumab regimens are allowed if administered in an IRB-approved clinical trial.
  • All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.
    Note: An ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy. If performed, its findings do NOT impact eligibility.
  • No neoadjuv endocrine therapy.
  • No neoadjuv RT.
  • No SLN surgery/excisional bx for path confirmation of axillary status prior to or during neoadjuv chemo.
  • No prior ipsilateral breast cancer (invasive or DCIS).  LCIS & benign breast disease is allowed.
  • No prior ipsilateral axillary surgery (i.e., excisional bx of LNs or hidradenitis tx).
  • No prior or concurrent contralateral invasive breast cancer.  Benign breast disease, LCIS, or DCIS of contralateral breast is allowed.
  • No pregnant or nursing women.  Negative serum or urine pregnancy test pre-regist (if applicable).
  • ECOG PS 0-1.
  • PRE-STUDY REQUIREMENTS:
    • H&P, VS, wt, ht, perf status, exam of axilla (surgeon, RO, MO, clinician, PA, or NP)*
    • Lymphedema asmt (companion study w/pt's consent)**
    • Lymphedema questionnaires (companion study w/pt's consent)**
    • Pathology requirements (see §6.5)**#
    • Ipsilateral mammo, breast US, axillary US (if done), MRI (if done) reports##
  • Signed informed consent.

*     Within 28 days pre-regist

**    After pre-regist & prior to surgery

#    At Registration/Randomization

##  From malignancy side obtained prior to start & after completion of neoadjuv chemo.

SEE PROTOCOL FOR INTRA-OP & POST-OP ELIGIBILITY CRITERIA






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