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SWOG S0226 - "Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post-Menopausal Women With Metastatic Breast Cancer"
Treatment Plan (Supplied Drugs: Anastrozole & Fulvestrant)
Arm 1 (Cycle = 28 days)
Anastrozole: 1mg, PO, QD
Until disease progression or symptomatic deterioration → Crossover to Fulvestrant
Arm 2 (Cycle = 28 days)
Cycle 1
Anastrozole: 1mg, PO, QD
Fulvestrant: 500mg (2 x 5mL), IM, Day 1
Fulvestrant: 250mg (1 x 5mL), IM, Days 14 & 28
Cycle 2
Anastrozole: 1mg, PO, Days 1-28
Fulvestrant: 250mg (1 x 5mL), IM, Day 28, q 28 days
Until disease progression or symptomatic deterioration → Off Protocol Tx
Eligibility
Path-confirmed dx of mets breast cancer (M1) or multiple sites of new disease that are clinically obvious mets disease.
Must be post-menopausal as defined by 1 of following:
Prior bilat oophorectomy
12 mos since LMP w/no prior hysterectomy
Age >55 w/prior hysterectomy
Age 55 w/prior hysterectomy without oophorectomy; estradiol and FSH must be consistent w/pt being post-menopausal
Must be ER+ or PgR+ or both w/positivity defined as estrogen binding >10fmol/mg cytosol protein by ligand binding assay or positive by IHC.
Must have meas or non-meas disease. CXR or chest CT w/i 42 days pre-regist. All xrays and scans for asmt of meas disease w/i 28 days pre-regist.
No prior chemo, hormonal, or immunotherapy for recur or mets disease. Prior adjuv or neoadjuv chemo is allowed if completed 12 mos pre-randomiz. Any number of prior hormonal therapy regimens for adjuv setting, but not for mets or recur disease is allowed. Prior adjuv or neoadjuv tx w/aromatase inhibitor or fulvestrant is allowed if completed >12 mos pre-randomiz.
Women who have taken LHRH analogue as adjuv therapy are eligible if they have: a) discontinued that therapy >12 mos pre-randomiz, and b) not resumed menstrual periods.
INR <1.6 w/i 28 days pre-regist.
No bleeding diathesis or long-term anti-coagulant therapy.
No brain or CNS mets.
Zubrod 0-2.
Pts who are participating in PK sampling must consent to the procedures. PK sampling is OPTIONAL.
Pts willing to participate in the tissue, serum, & whole blood sample submissions must consent to the procedures.
No planned chemo or hormone (including HRT) for malignancy while receiving protocol tx.
No known HIV positive pts.
No other prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, adequately treated Stg I or II cancer currently in complete remission, or any other cancer disease-free > 5 yrs.
PRESTUDY REQUIREMENTS:
H&P, wt, perf status, disease asmt
CBC/diff/platelets*
Serum creat*
Bili*
SGOT or SGPT, alk phos*
INR
Pharmacokinetic sample** (w/pt's consent)
Tumor sample (required to seek additional pt consent)***
Serum sample (encouraged)#
Whole blood sample (encouraged)&
Xrays/Scans prn tumor msmt
* Suggested prestudy for good medical practice
** 15ml of blood will be drawn at baseline and at 4-6 other timepoints (depending on Arm), prior to Anastrozole or Fulvestrant administration. An additional 10cc of blood will also be drawn for estradiol level. Process per protocol and notify Quest for immediate pickup (1/800-877-7004, x2277).
*** Submit 1 block of prim tumor (or a punch of the block plus 25 unstained 5-micron sections on plus slides) to: Lab #107; Univ. of Cincinnati; Cincinnati, OH.
# Serial serum levels will be drawn prior to Cycle 1, and at each eval point prior to receiving tx on Cycles 2, 3, 4, & 7. Collect one SST vacutainer tube, preferably under fasting conditions. Process per protocol and ship on dry ice via overnight delivery to: Lab #78; SWOG Sold Tumor Tissue Bank; Univ. of Colorado HSC at Fitzsimmons.
& 10mL whole blood. Process per protocol and ship on cold pack (NOT dry ice) via overnight delivery to: Lab #78; SWOG Sold Tumor Tissue Bank; Univ. of Colorado HSC at Fitzsimmons.
Signed informed consent.