This multicenter, randomized, double-blind, phase II study aims to show improvement in the rate of mucositis/stomatitis (WHO´s OTS) grade 2-4 at 12 weeks after start of treatment by comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema starting with a low dose over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.
- Conditions
- Advance Breast cancer under endocrine treatmentMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005126-35-DE
- Lead Sponsor
- GBG Forschungs GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 156
- Locally advanced or metastatic stage of disease not amenable to curative treatment by surgery or radiotherapy alone.
- No indication for chemotherapy (e.g. symptomatic visceral metastasis)
-Histological confirmed hormone receptor-positive (HR+), HER2-negative carcinoma of the breast.
- Postmenopausal women
- Disease progression following prior therapy with non steroidal aromatase inhibitors (NSAI), defined as:
a. Recurrence while on, or following completion of an adjuvant treatment with Letrozole or Anastrozole, or
b. Progression while on or following completion of Letrozole or Anastrozole treatment for ABC/MBC.
Note: Non-steroidal aromatase inhibitors (i.e. Letrozole or Anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. Tamoxifen, Fulvestrant, Exemestane, is also allowed. Patients must have
recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.
- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation field or there must be pathologic proof of newly progressive disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156
- Concurrent immunotherapy or hormonal therapy (contraceptive and/or replacement therapy). Bisphosphonates or denosumab may be continued or started before randomization.
- Life expectancy of less than 3 months.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy.
-Any ongoing toxicity from prior anti-cancer therapy that is grade 3-4 and/or that is progressing in severity, except alopecia or anemia controlled by growth factors.
-Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring anti-anginal medication, previous history of myocardial infarction = 6months, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- Currently active infection.
-History of other malignancies within the last 5 years which significantly affect the diagnosis, assessment or prognosis of metastatic breast cancer.
-Malabsorption syndrome or insufficient gastrointestinal function, preexisting diagnosis of ulcerative colitis.
-Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
-Insufficiently controlled diabetes, known HIV infection or chronic hepatitis B or C and seriously impaired liver function (Child-Pugh, class A, B or C).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method