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Phase II Trial Of PS-341 In Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

Phase II Trial Of PS-341 In Metastatic Breast Cancer


I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic
breast cancer.


I. Determine the clinical activity of this drug, in terms of progression-free survival, in
these women.

II. Determine the toxicity profile and tolerability of this drug in these women.

III. Determine the pharmacodynamics of this drug in these women.


Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer

- Clinical and/or radiological evidence of stage IV disease

- Relapsed or resistant disease within 6-12 months after completion of prior
chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel
foradvanced disease or in the adjuvant setting

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques

- At least 10 mm by spiral CT scan

- No bone metastases as only measurable site

- Pleural or peritoneal effusions not acceptable as measurable disease

- No known brain metastases

- Hormone receptor status:

- Estrogen receptor-negative

- Estrogen receptor-positive

- Female

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 12 weeks

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

- AST or ALT no greater than 2.5 times upper limit of normal

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No acute ischemia or significant conduction abnormality by EKG

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- LVEF greater than 50%

- No uncontrolled concurrent illness

- No psychiatric illness or social situation that would preclude study

- No ongoing or active infection

- No prior allergic reaction(s) to compounds of similar chemical or biologic
composition to PS-341

- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
basal cell skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier-method contraception

- See Chemotherapy

- See Disease Characteristics

- No more than 1 prior chemotherapy regimen for metastatic disease

- High-dose regimen or bone marrow transplantation considered 1 prior regimen

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and

- Prior hormonal therapy for metastatic disease or in adjuvant setting allowed

- Prior localized radiotherapy allowed if it does not influence the signal evaluable

- At least 4 weeks since prior radiotherapy and recovered

- At least 2 weeks since prior minor surgery and recovered

- At least 4 weeks since prior major surgery and recovered

- No other concurrent investigational agent

- No other concurrent investigational or commercial agents or therapies to treat this

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response (CR + PR)

Outcome Description:

The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).

Outcome Time Frame:

Up to 24 months

Safety Issue:


Principal Investigator

Massimo Cristofanilli

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms



M D Anderson Cancer Center Houston, Texas  77030