Advertisement

Topics

Hormone Therapy and OSI-906 With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic Breast Cancer

2014-08-27 03:17:58 | BioPortfolio

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole or goserelin may fight breast cancer by lowering the amount of estrogen the body makes. OSI-906 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy and OSI-906 are more effective when given with or without erlotinib hydrochloride in treating breast cancer.

PURPOSE: This phase II trial is studying how well giving hormone therapy together with OSI-906 with or without erlotinib hydrochloride works in treating patients with metastatic breast cancer.

Description

OBJECTIVES:

Primary

- To determine the antitumor activity of letrozole or goserelin in combination with IGF-1R inhibitor OSI-906 with or without erlotinib hydrochloride, in terms of time to progression, in patients with hormone-sensitive metastatic breast cancer.

Secondary

- To determine the safety of these regimens in these patients.

- To determine the response rate in patients treated with these regimens.

- To measure circulating C-peptide, IGF-1, and IGFBP-3 levels in patients treated with these regimens.

- To correlate the expression of IGF-IR, EGFR, HER2, Y1316 and Y1131 pIGF-1R, PTEN, S473 pAkt, pMAPK, S118 (MAPK site), and S167 (Akt and S6 site) pER in formalin-fixed paraffin blocks (FFPB) with clinical outcome and different subtypes of breast cancer.

- To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and different subtypes of breast cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to prior endocrine therapy (yes vs no), and disease recurrence after > 6 months after completion of adjuvant therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral letrozole once daily on days 1-28 or goserelin* subcutaneously on day 1 and oral IGF-1R inhibitor OSI-906 twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive letrozole or goserelin* and IGF-1R inhibitor OSI-906 as in arm I. Patients also receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Goserelin will only be given to premenopausal patients.

Tumor tissue samples from original diagnosis or from fresh biopsy are collected for biomarker analysis and other studies.

After completion of study therapy, patients are followed up periodically.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

IGF-1R inhibitor OSI-906, erlotinib hydrochloride, goserelin, letrozole

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:58-0400

Clinical Trials [6129 Associated Clinical Trials listed on BioPortfolio]

Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may s...

Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an effecti...

Letrozole in Treating Women With Primary Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet kn...

Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer

This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cel...

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). ...

PubMed Articles [17368 Associated PubMed Articles listed on BioPortfolio]

Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study.

Endocrine treatment (ET) with an aromatase inhibitor (AI) is the treatment of choice in post-menopausal patients with hormone receptor-positive early breast cancer (EBC). However, adverse events (AEs)...

miR-1271 inhibits ERα expression and confers letrozole resistance in breast cancer.

Attenuation of estrogen receptor α (ERα) expression via unknown mechanism(s) is a hallmark of endocrine-resistant breast cancer (BCa) progression. Here, we report that miR-1271 was significantly dow...

Effects of proton pump inhibitor co-administration on the plasma concentration of erlotinib in patients with non-small cell lung cancer.

Erlotinib is used for treating non-small cell lung cancer (NSCLC). Intestinal absorption of erlotinib is impaired under gastric pH elevation, therefore, co-administration of gastric acid suppressants ...

Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study.

Non-inferiority in the cumulative castration rate of the 3-month formulation of degarelix compared with the 3-month formulation of goserelin was evaluated in subjects with prostate cancer. A phase III...

Combined effects of neoadjuvant letrozole and zoledronic acid on γδT cells in postmenopausal women with early-stage breast cancer.

Adjuvant bisphosphonates lead to better prognosis in postmenopausal breast cancer. However, the association between clinical outcomes and immune modulation by them is still unclear.

Medical and Biotech [MESH] Definitions

A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A selective aromatase inhibitor effective in the treatment of estrogen-dependent disease including breast cancer.

More From BioPortfolio on "Hormone Therapy and OSI-906 With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...


Searches Linking to this Trial