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Report for Clinical Trial NCT01013506

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Trial of Endocrine Therapy in Combination With OSI-906 (an IGF-1R Inhibitor) With or Without Erlotinib (Tarceva, an EGFR Inhibitor) in Patients With Hormone-sensitive Metastatic Breast Cancer.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole +/- goserelin (the latter for pre-menopausal women only) 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 hormone-sensitive metastatic 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 hormone-sensitive patients with metastatic breast cancer.

NCT01013506 Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

4 Interventions

Name: IGF-1R inhibitor OSI-906

Description: Given orally
Type: Drug
Group Labels: 2

Letrozole +/- goserelin, OSI-906, erlotinib (Arm II) Letrozole +/-goserelin, OSI-906 (Arm I )

Name: erlotinib hydrochloride

Description: Given orally
Type: Drug
Group Labels: 1

Letrozole +/- goserelin, OSI-906, erlotinib (Arm II)

Name: goserelin

Description: Given subcutaneously
Type: Drug
Group Labels: 2

Letrozole +/- goserelin, OSI-906, erlotinib (Arm II) Letrozole +/-goserelin, OSI-906 (Arm I )

Name: letrozole

Description: Given orally
Type: Drug
Group Labels: 2

Letrozole +/- goserelin, OSI-906, erlotinib (Arm II) Letrozole +/-goserelin, OSI-906 (Arm I )


Primary Outcomes

Description: Duration from study enrollment to date of progressive disease (PD) as measured by Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: PD is > 20% increase in the sum of the longest diameter of target lesions or appearance of new lesions

Measure: Time to progression

Time: from study entry to date of progressive disease

Secondary Outcomes

Description: The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death

Measure: Safety profile of OSI-906 and letrozole +/ goserelin, with and without erlotinib

Time: at 4 weeks

Description: Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions

Measure: Response

Time: every 12 weeks to progression

Description: Levels of the protein C-peptide and the hormone IGF-1 in the blood

Measure: Circulating C-peptide, IGF-1

Time: At baseline and on day 1 of each 28-day cycle

Description: The levels of these biomarkers will be measured in breast tumor tissue and compared and contrasted with patient's time to progression and molecular classification (luminal A vs. luminal B)

Measure: Correlation of IGF-IR, EGFR, HER2, Y1316 and Y1131 pIGF-1R, PTEN, S473 pAkt, pMAPK, S118 (MAPK site), and S167 (Akt and S6 site) pER expression with time to progression and molecular classification

Time: On receipt of breast tissue: tissue block from prevous surgery or fresh tissue from current surgery

Description: Breast tumor tissue will be examined for mutations in these genes.

Measure: Mutation analysis of PI3K (E542K, E545K, H1047R)

Time: On receipt of breast tissue: tissue block from prevous surgery or fresh tissue from current surgery

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 E542K

Mutation analysis of PI3K (E542K, E545K, H1047R). --- E542K ---

- To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and luminal A vs. luminal B subtypes of breast cancer OUTLINE: This is a multicenter study. --- E542K ---


2 E545K

Mutation analysis of PI3K (E542K, E545K, H1047R). --- E542K --- --- E545K ---

- To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and luminal A vs. luminal B subtypes of breast cancer OUTLINE: This is a multicenter study. --- E542K --- --- E545K ---


3 H1047R

Mutation analysis of PI3K (E542K, E545K, H1047R). --- E542K --- --- E545K --- --- H1047R ---

- To correlate the mutational status of PI3K (E542K, E545K, H1047R) in DNA extracted from FFPB or fresh biopsy with clinical outcome and luminal A vs. luminal B subtypes of breast cancer OUTLINE: This is a multicenter study. --- E542K --- --- E545K --- --- H1047R ---



HPO Nodes


HPO: