Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	any age	NCI	SWOG-9115 EST-1192, INT-0127

Objectives

I.  Compare overall survival and time to treatment failure of patients with 
poor-prognosis recurrent or metastatic breast cancer who are in complete or 
partial remission following standard induction therapy and who are randomly 
assigned to receive consolidation with STAMP V (high-dose 
cyclophosphamide/thiotepa/carboplatin) with autologous stem cell rescue vs. 
further chemotherapy with the same induction regimen.

Entry Criteria

Disease Characteristics:

Histologically confirmed, recurrent or metastatic breast cancer
with maximum clinical response (CR or PR) after induction
therapy, as follows:

  Patients in CR (including Stage IV disease currently NED)
  may have had response assessed based on measurable or
  evaluable disease

  Patients in PR must have had 1 bidimensionally measurable
  site of disease that was documented with a PR with no
  evidence of progression at any other site of disease
  (including bone)

     Bidimensionally measurable lesions defined as either:

        Skin lesion or lesion on x-ray or scan with at
        least 1 diameter greater than 0.5 cm (no bone
        lesions)

        Palpable lesion with both diameters at least 2 cm

  PR/CR must be documented within 28 days prior to registration

  No bone only disease

  No CNS metastases on brain CT or MRI within 42 days prior
  to registration

  Bone marrow must be normal on light microscopy within 42
  days prior to registration

Hormone receptor status (determined on either the primary tumor
or biopsied metastasis) must meet one of the following
categories:
  ER-negative (less than 10 fmol/mg cytosol protein) and
  PgR-negative (less than 10 fmol/mg cytosol protein); or
  ER-unknown/PgR-negative; or ER-negative/PgR-unknown

  ER-positive and/or PgR-positive or ER/PgR-unknown with
  hepatic or lymphangitic pulmonary metastases

  ER-positive and/or PgR-positive or ER/PgR-unknown following
  failure on hormonal therapy (except for patients with liver
  or lymphangitic pulmonary disease)

     Failure on hormonal therapy defined as follows:

        Relapse while on or within 12 months of having
        completed adjuvant hormonal therapy

        Disease progression following no response to 
        hormonal therapy for advanced disease (but not
        following CR or PR to hormonal therapy for
        advanced disease)

Registration required within 7 months of initiation of
induction chemotherapy

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  One prior chemotherapy regimen for metastatic disease to
  maximum clinical response required
     A maximum of 2 additional courses allowed after
     registration but prior to transplantation

     No more than 6 courses total allowed

     Stage IV patients who are NED must receive at least 2
     courses of chemotherapy prior to transplantation

  No prior nitrosoureas or mitomycin

  Cumulative prior doxorubicin dose must not exceed 400 mg/sqm

  At least 6 months between completion of any prior adjuvant
  chemotherapy and diagnosis of recurrence

Endocrine therapy:
  Prior hormonal therapy for advanced disease allowed provided,
  if it was the most recent therapy, no response (PR or CR) was
  obtained

Radiotherapy:
  No prior pelvic radiotherapy allowed

Surgery:
  Not specified

Other:
  Transplant must be planned at a designated center

Patient Characteristics:

Age:  
  Any age

Performance status:
  0 or 1

Hematopoietic:
  (obtained within 14 days prior to registration)
  AGC greater than 1,000
  Platelets above institutional lower limit of normal

Hepatic:
  (obtained within 14 days prior to registration)
  Bilirubin less than 2 x institutional ULN

Renal:
  (obtained within 14 days prior to registration)
  Creatinine less than 1.5 x institutional ULN

Cardiovascular:
  No history of CHF
  LVEF at least 45% on MUGA within 42 days prior to
     registration

Pulmonary:
  (obtained within 42 days prior to registration)
  FEV1 greater than 60% of predicted
  Lung volume greater than 60% of predicted
  DLCO greater than 60% of predicted

Other:
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     In situ carcinoma of the cervix
  Appropriate third-party insurance coverage or documentation
     of ability to pay for treatment required
  No pregnant or lactating women
  Effective contraception required of fertile women

Expected Enrollment

150 patients will be randomized to each arm.  It is estimated that the annual 
registration rate will be 120 patients and that 2.5 years of accrual will be 
required.

Outline

Randomized study.  Patients randomized to Arm A are offered stem cell harvest, 
but only patients randomized to Arm B receive stem cell infusion on protocol.  
Receptor-positive patients who have not had prior exposure to tamoxifen are 
treated on Regimen A after completion of chemotherapy on Arm I or after 
recovery from bone marrow therapy on Arm II.

Arm A:  No Bone Marrow Transplantation.  Continuation of induction 
chemotherapy.

Arm B:  3-Drug Combination Marrow-Ablative Chemotherapy followed by Autologous 
Stem Cell Infusion.  STAMP V:  Cyclophosphamide, CTX, NSC-26271; Thiotepa, 
TSPA, NSC-6396; Carboplatin, CBDCA, NSC-241240; followed by infusion of 
autologous bone marrow or peripheral blood stem cells.

Regimen A:  Antiestrogen Therapy.  Tamoxifen, TMX, NSC-180973.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Robert Livingston, MD, Protocol chair(Contact information may not be current)		Ph: 206-288-2034

Eastern Cooperative Oncology Group

M. John Kennedy, MD, Protocol chair		Ph: 353-1-416-2169 Email: jkennedy@stjames.ie

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