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Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Post-menopausal, Estrogen Receptor Positive, Breast Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Post-menopausal, Estrogen Receptor Positive, Breast Cancer Patients

Primary Objective:

To compare the activity of the 2 regimens The primary end point will be the clinical
complete response rate of each treatment arm among all registered cases (intent to treat

Secondary Objectives:

To compare the 2 treatment arms with respect to:

- Toxicity

- Progression Free Survival

- Overall survival

Ancillary studies To evaluate before and after treatment a number of markers of hypoxia,
neoangiogenesis, apoptosis, EGFR activating pathways.

Inclusion Criteria:

- 1. Women in postmenopausal status

- 2. Age> 60 or age > 18 and unfit for chemotherapy with commonly employed regimens in
breast cancer patients

- 3. Diagnosis of invasive BC, T>2, N0-N2, M0,

- 4. Endocrine Responsive disease according to San Gallen criteria

- 5. ECOG Performance Status of 0 or 2

- 6. Life expectancy of at least 12 weeks

- 7. In case of recent surgery, the wound must be completely healed prior to receiving

- 8. Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional(for WHO)
measurable lesion. Lesions must be measured by CT-scan or MRI

- 9. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

- 10. Hemoglobin > 9.0 g/dl

- 11. Absolute neutrophil count (ANC) >1,500/mm3

- 12. Platelet count 100,000/μl

- 13. Total bilirubin < 1.5 times the upper limit of normal

- 14. ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for
patients with liver involvement of their cancer)

- 15. Alkaline phosphatase < 4 x ULN

- 16. PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically
anticoagulated with an agent such as coumadin or heparin will be allowed to
participate provided that no prior evidence of underlying abnormality in these
parameters exists.]

- 17. Serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

- 1. History of cardiac disease:congestive heart failure >NYHA class 2;active CAD (MI
more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring
anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled

- 2. History of HIV infection or chronic hepatitis B or C (This criteria should be
modified to allow Hepatitis B or C in protocols looking at HCC patient population).

- 3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

- 4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months
from definitive therapy, has a negative imaging study within 4 weeks of study entry
and is clinically stable with respect to the tumor at the time of study entry)

- 5. Patients with seizure disorder requiring medication (such as steroids or

- 6. History of organ allograft The organ allograft may be allowed as protocol

- 7. Patients with evidence or history of bleeding diathesis

- 8. Patients undergoing renal dialysis

- 9. Previous or concurrent cancer that is distinct in primary site or histology from
the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated
basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer
curatively treated > 3 years prior to study entry

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

six years

Safety Issue:


Principal Investigator

Alfredo Berruti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical Oncology, Department of clinical and biological sciences Univerity of Turin


Italy: The Italian Medicines Agency

Study ID:

EudraCT 2007-006208-39



Start Date:

September 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • neoadjuvant therapy, sorafenib, letrozolo, cyclophosphamide
  • Breast Neoplasms