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Closed (no longer recruiting)Last updated: 20 December 2023

CT618: This phase I trial is investigating the future development of LEE011 and BYL719 in the treatment of advanced oestrogen receptor positive breast cancerA Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Clinical summary

Summary

Cabrini & Northern Phase II only. This study will investigate the combination of LEE011 (CDK4/6i) and BYL719 (PI3K-alpha-i) with letrozole in patients with ER+/HER2- breast cancer (BC). In Phase Ib there are three dose escalation cohorts that will enroll sequentially. Arm 1 is the escalation of the double combination LEE011 + letrozole; Arm 2 is the dose escalation of the double combination of BYL719 + letrozole. The two double combinations will be followed by Arm 3 the dose escalation of the triple combination of LEE011 + BYL719 with letrozole. The three dose escalation cohorts will enroll patients with ER+/HER2- BC with any number of prior lines of endocrine therapy with up to one prior cytotoxic regimen in the metastatic or locally advanced setting. Pre- and post-treatment tumor biopsies are required in the three dose escalation cohorts. Once the RP2D/MTD of each double regimen is identified, dose expansion cohorts of each of these two combinations will open and will enroll in the first-line setting to confirm the doses selected in each double combination; archival tumor tissue is required in these cohorts, although pre- and post-biopsies in these expansion cohorts are optional. Once the dose is identified for the triple combination, the randomized, three-arm Phase II portion of the study will commence enrollment. This part of the trial will enroll in the first line setting in patients with ER+/HER2- BC and will randomize patients in a 1:1:1 ratio to either double regimen (LEE011+letrozole or BYL719 +letrozole) or the triple combination of LEE011+BYL719 with letrozole.

Conditions

This trial is treating patients with oestrogen receptor positive breat cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

I/II

Trial Acronym

CT618

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Eligibility

Inclusion

  • Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer
  • Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
  • Phase Ib dose expansions Arms 1, 2 and 3
  • No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
  • Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment.

Exclusion

  • HER2-overexpression in the patient's tumor tissue
  • Patients with active CNS or other brain metastases
  • Major surgery within 2 weeks
  • Acute or chronic pancreatitis
  • Bilateral diffuse lymphangitic carcinomatosis
  • Another malignancy within 3 years
  • Receiving hormone replacement therapy that cannot be discontinued
  • Impaired cardiac function
  • Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
  • Other protocol-defined inclusion/exclusion criteria may apply

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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