Breast Cancer Clinical Trial
Official title:
Phase Ib Followed by Phase II Study of Pre-operative Treatment With Lenvatinib Combined With Letrozole in Post-menopausal Women With Newly Diagnosed Hormone Receptor Positive Breast Cancer With Measurable Primary Breast Tumor
This is a single-centre study comprising two phases: a lead-in phase Ib and a phase II
randomized portion.
Lead-in Phase Ib study A lead-in phase I study will be built into this protocol to confirm
the dose of lenvatinib that can safely be combined with letrozole.
We expect that the optimal phase II dose level will be determined after recruiting 12-18
subjects into phase Ib. This dose level will be the one to be tested in the phase II portion
of the study.
Phase II open label study In this part of the study, eligible patients will be treated with
single agent lenvatinib at the phase II recommended dose for 2 weeks, followed by lenvatinib
combined with letrozole 2.5mg daily for 12 weeks.
A total of 30 patients with ER positive breast cancer and measurable primary tumor will be
enrolled over a period of 24-30 months
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female, age = 18 years. - Histologic or cytologic diagnosis of breast carcinoma. - Part A: T1-4 breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper. Newly diagnosed metastatic patients with measurable primary breast tumor =2cm are eligible provided that there are plans for toilet mastectomy after completing 14 weeks of pre-operative drug therapy. Patients must not have received prior chemotherapy or hormonal therapy for the treatment of the current breast cancer. - Part B: Patients with metastatic breast cancer with measurable tumor by RECIST criteria.Patients previously treated with letrozole are eligible if they progressed on letrozole =1 year after adjuvant treatment, or = 6 months in the metastatic setting. - ECOG 0-1. - Estimated life expectancy of at least 12 weeks. - Adequate organ function including the following: - Bone marrow: - Absolute neutrophil (segmented and bands) count (ANC) = 1.5 x 109/L - Platelets = 100 x 109/L - Hepatic: - Bilirubin = 1.5 x upper limit of normal (ULN), - ALT or AST = 2.5x ULN, (or =5 X with liver metastases) - Renal: Creatinine = 1.5x ULN • Post-menopausal women. Post-menopausal status is defined either by - Age = 60 years and one year or more of amenorrhea - Age < 60 years and one year or more of amenorrhea (in the absence of ovarian suppression) and with estradiol and FSH levels consistent with menopause, *Treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression for Part A (patients with non-metastatic disease receiving the study treatment as neoadjuvant therapy). However, in Part B (patients with metastatic disease), pre-menopausal women who are treated with medical ovarian suppression with post-menopausal levels of estradiol (institutional limits) at time of study entry and who will continue to be suppressed with 4-weekly LHRH agonist during study treatment may be enrolled. If these patients were previously on 12-weekly long-acting LHRH agonist, this has to be switched to 4-weekly LHRH agonist while the patient is on study treatment. • Signed informed consent from patient or legal representative. Exclusion Criteria: - Treatment within the last 30 days with any investigational drug. - Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. - Major surgery within 28 days of study drug administration. - Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. - Pregnancy. - Breast feeding. - Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. - Active bleeding disorder or bleeding site. - Non-healing wound. - Poorly controlled diabetes mellitus. - Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. - Symptomatic brain metastasis. - History of significant neurological or mental disorder, including seizures or dementia. |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | Eisai Co., Ltd. |
Singapore,
Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. — View Citation
Spanheimer PM, Park JM, Askeland RW, Kulak MV, Woodfield GW, De Andrade JP, Cyr AR, Sugg SL, Thomas A, Weigel RJ. Inhibition of RET increases the efficacy of antiestrogen and is a novel treatment strategy for luminal breast cancer. Clin Cancer Res. 2014 Apr 15;20(8):2115-25. doi: 10.1158/1078-0432.CCR-13-2221. Epub 2014 Feb 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of clinical response | Complete and partial clinical response, including confidence intervals. | 2-3 weeks | |
Secondary | Rates of pathological complete responses. | A pathological complete responder is defined as any patient who demonstrates no histological evidence of invasive tumor in the primary breast site as well as in resected axillary lymph nodes | 4-6 weeks | |
Secondary | Progression-free survival | Time to documented disease progression is defined as the time from the date of study enrollment to the first date of documented disease progression. Time to documented disease progression will be censored at the date of death for patients who have not had documented disease progression. For patients who are still alive at the time of analysis and who have not had documented disease progression, time to documented disease progression will be censored at the date of the last follow-up visit. | 2 - 5 year |
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