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 NCORP-KC for complete protocol information.



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Breast Clinical Trial

CANCER TYPE: Stage III
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 & <96 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.
  • Completed all planned chemo prior to surgery.  Sandwich chemo not allowed.  Completed >6 cycles of neoadjuv chemo consisting of an anthracycline &/or taxane-based regimen w/o evidence of disease progression in breast or lymph nodes.  See §4.1.7 for details.
  • 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.
  • Clinically negative axilla (no palpable LNs or bulky adenopathy) on PE at completion of neoadjuv chemo.  US of axilla is not required at completion of neoadjuv chemo.  If done, 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).
  • Zubrod 0-1.
  • PRE-STUDY REQUIREMENTS:
    • H&P, VS, wt, ht, perf status, exam of axilla (surgeon, RO, MO, clinician, PA, or NP)*
    • Serum or urine ß-HCG (if applicable)*
    • 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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