Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | January 2014 |
| End Date: | December 8, 2017 |
Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is
prevents cells from producing estrogens. This should assist with the slowing of growth of
tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction
pathway.
The objectives of this study will look at the differences between the cellular destruction
pathway before and after letrozole use, and the differences in the cellular destruction
pathway in participants that have received letrozole versus those who did not. The study will
also look at a gene in all participants called Ki67. This gene is associated with the rate of
tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount
of activation of the cellular destruction pathway.
Participants in this study will have undergone a diagnostic biopsy of their breast tissue.
In order to meet these objectives, one group of participants (Arm A) will not receive
letrozole. Tissue leftover from their diagnostic biopsy will be treated with everolimus
(RAD001) in the laboratory and the effects of this drug on the cellular destruction pathway
will be studied.
The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum
of 21 days. They will have a second tumor sample taken as part of their surgical procedure
completed to remove the tumor tissue. Any differences in the cellular destruction pathway
before and after exposure to letrozole will be measured.
prevents cells from producing estrogens. This should assist with the slowing of growth of
tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction
pathway.
The objectives of this study will look at the differences between the cellular destruction
pathway before and after letrozole use, and the differences in the cellular destruction
pathway in participants that have received letrozole versus those who did not. The study will
also look at a gene in all participants called Ki67. This gene is associated with the rate of
tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount
of activation of the cellular destruction pathway.
Participants in this study will have undergone a diagnostic biopsy of their breast tissue.
In order to meet these objectives, one group of participants (Arm A) will not receive
letrozole. Tissue leftover from their diagnostic biopsy will be treated with everolimus
(RAD001) in the laboratory and the effects of this drug on the cellular destruction pathway
will be studied.
The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum
of 21 days. They will have a second tumor sample taken as part of their surgical procedure
completed to remove the tumor tissue. Any differences in the cellular destruction pathway
before and after exposure to letrozole will be measured.
Inclusion Criteria:
- Histologic Documentation of invasive breast cancer by core needle or incisional
biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections
must be available for molecular analyses as part of this study.
- The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining
present in greater than 50% staining of invasive cancer cells by IHC.
- The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative
(IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is
2+ or if IHC has not been done).
- Clinical stage I-III invasive breast cancer with the intent to treat with surgical
resection of the primary tumor. Tumor must be ≥ 2cm to provide adequate tissue.
- Patients with multi-centric or bilateral disease are eligible if the target lesions
meet the other eligibility criteria. Samples from all available tumors are requested
for research purposes.
- Women ≥ age 18, for whom adjuvant treatment with an aromatase inhibitor would be
clinically indicated. Women must be either post-menopausal, or pre-menopausal having
undergone oophorectomy.
- Patients must meet the following clinical laboratory criteria:
Absolute neutrophil count (ANC)≥ 1000/mm3 and platelet count ≥ 75,000/mm3. Total bilirubin
≤ 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤ 3 x ULN.
- Ability to give informed consent.
Exclusion Criteria:
- Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior
endocrine therapy that was administered ≥ 5 years ago for the prevention of breast
cancer in patients with no history of breast cancer is allowed.
- Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.
- Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other
anti-cancer agent besides Letrozole (10-21)days before surgical resection of the
primary tumor).
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Gary Schwartz, MD
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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