CTSU PACCT-1 - "Program for the Assessment of Clinical Cancer Tests (PACCT-1):  Trial Assigning IndividuaLized Options for Treatment:  The TAILORx Trial"

Treatment Plan    (Supplied Drug:  None)

PRE-REGISTRATION

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Submit tumor specimen to Genomic Health for ONCOTYPE DX Assay (MANDATORY - contact KCCOP for kit)

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REGISTRATION/RANDOMIZATION

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Submit pre-tx frozen tissue & perip blood specimens to ECOG PCO-RL (contact KCCOP for kits)

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Secondary Study Group - 1 (Recurrence Score <11)  à Arm A (Hormonal Therapy) + QOL Asmt

Primary Study Group - 1 (Recurrence Score 11-25)  à Randomized to Arm B (Hormonal Therapy) + QOL Asmt or

                                                                                                         Arm C (Chemo + Hormonal Therapy) + QOL Asmt

Secondary Study Group - 2 (Recurrence Score >25)  à Arm D (Chemo + Hormonal Therapy) + QOL Asmt

SEE PROTOCOL FOR RECOMMENDED CHEMO & HORMONAL THERAPY REGIMENS. 

Type of Chemo &/or Hormonal Therapy at treating physician's discretion.

QOL Asmts completed at baseline, 3, 6, 12, 24, & 36 months.

Eligibility

PRE-REGISTRATION

• Must have operable histol-confirmed female breast adenocarcinoma and completed primary surgical tx.  Must meet following:

  • ER &/or PR-positive:  ER &/or PR+ disease (defined by local path lab)

  • Negative axillary nodes:  Assessed by SLN bx, axillary dissection, or both (see protocol for further information)

  • Tumor size 1.1-5.0cm (or 5mm-1.0cm plus unfavorable histological features:  Unfavorable features defined as intermediate or poor nuclear &/or histol grade or lymphovascular invasion (see protocol for further information)

  • Her2/Neu negative:  By either FISH or immunohistochemistry (0 or 1+ by DAKO Herceptest)

• Pt and physician must agree to initiate standard chemo & hormonal therapy as adjuv therapy.  See protocol for permitted tx options.

• Tissue specimen from prim breast cancer must be located and ready for shipment after consent is obtained and w/i 3 days following pre-regist.  NOTE:  For determination of Oncotype Recurrence Score, tissue must be shipped to Genomic Health.  If Oncotype Recurrence Score was previously performed by Genomic Health (prior to pre-regist), tissue must be submitted to the ECOG Path Coordinating Office upon randomization.

• Age >18 & <75.

• Within 4 wks pre-regist:   Leukocytes >3500/mm3; platelets >100,000/mm3; serum creat <1.5mg/dL; SGOT <3x IULN.

• Disease-free of prior invasive malignancies >5 yrs except for curatively-treated non-melanoma skin cancer or in situ cervical carcinoma.  No previous ipsilateral or contralateral invasive breast cancer or bilat synchronous cancers.  No previous ipsilateral or contralateral DCIS.

• Mandatory prior surgery criteria:

  • Pt must pre-register w/i 84 days from final surgical procedure to adequately treat the prim tumor.  If margins are not clear & a resection has to be done after pre-regist, but b/f randomiz, the pt will be considered w/i the 84-day window & therefore eligible.

  • All tumors removed by either mastectomy or local excision + acceptable axillary procedure (SLN bx, axillary dissection, or both).  >1mm  (if margin width specified) tumor-free margins of resection (for invasive & DCIS).  LCIS involving resection margins is allowed.

• No prior chemo or RT (including MammoSite Brachytherapy) for this malignancy.

• No pts who develop breast cancer while receiving a SERM or aromatase inhibitor for breast cancer prevention or a SERM for other indications (i.e., osteoporosis).  However, <8 wks of a SERM or aromatase inhibitor for this malignancy is allowed.

• Life expectancy >10 yrs.  No pts w/COPD requiring tx, chronic liver disease, previous CVA, hx of CHF or other cardiac disease that contraindicates use of an anthracycline, or chronic psychiatric or other condition to preclude tx compliance.

• No pregnant or nursing women.  If childbearing potential, must have negative blood or urine pregnancy test w/i 2 wks prior to pre-regist.  Strongly advised to use effective non-hormonal contraception.

• No pts previously having Oncotype DX Assay performed, except pts who had assay performed w/Recurrence Score of 11-25. 

• PRESTUDY REQUIREMENTS:

  • H&P, ht, wt

  • CBC, w/leukocytes & platelets (<4 wks pre-regist)

  • Serum creat & SGOT (<4 wks pre-regist)

  • Mammography &/or Breast MRI#

  • Oncotype DX Assay (RS score)

  • Tumor tissue, fixed paraffin-embedded (MANDATORY from pts w/no RS score determined prior to pre-regist.  Ship w/i 3 days following pre-regist.)

  • Tumor tissue, fixed paraffin-embedded (for central review & banking for future research)*

  • Frozen tumor tissue (if available)*

  • Plasma, EDTA purple top*

  • Serum, SST*

  • Perip blood, citrate CTP*

  • Perip blood PAXgene DNA*

  • Pregnancy test (if applicable; w/i 2 wks prior to pre-regist)

  • QOL Asmts (6 forms)

        *  With pt's consent, collect after regist/randomiz prior to start of tx.  See protocol for processing/storage requirements.

      #  Mammogram &/or breast MRI obtained as part of original dx, bx, & surgical tx will suffice & do not need to be repeated.  Bilat MRI alone is acceptable if mammography could not be performed.

• Signed informed consent.

REGISTRATION (24-72 hrs after submission of Oncotype DX Assay Report)