A Randomized Trial with factorial Design comparing Fulvestrant ± Lapatinib ± Aromatase Inhibitor in metastatic breast cancer progressing after Aromatase Inhibitor therapy - OVER

Active, not recruiting

• Conditions: breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2007-006031-30-IT
• Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent
2.Histological/cytological confirmation of breast cancer
3.Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
4.Postmenopausal women, defined as a woman fulfilling any 1 of the following criteria:
Aged  60
Aged 45-59 and satisfying one or more of the following criteria
amenorrhea for 12 months and intact uterus;
amenorrhea for 12 months and FSH* within the postmenopausal range, including:
pts with hysterectomy
pts who have received HRT
pts with chemotherapy-induced amenorrhea
bilateral oophorectomy at any age >18 years.
*In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomization and menses must not have restarted
5.Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
6.Patients demonstrating prior response to AI therapy (AI response >2y on adjuvant AI, or CR, PR, SD> 24weeks if receiving AI for advanced disease)
7.Patients fulfilling one of the following criteria:
Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible.
8.May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
9.Life expectancy of at least 8 months in the best judgement of the investigator
10.WHO performance status 0, 1 or 2
11.Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;
12.Are able to swallow and retain oral medication;
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous therapy with Fulvestrant and/or Lapatinib;
2.Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
3.Concurrent non study anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication; the treatment with bisphosfonates is admitted;
4.Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
5.Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;
6.Have a concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical disorder that would interfere with the patient safety;
7.Have an active or uncontrolled infection;
8.Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
9.Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
11.Receive concurrent treatment with prohibited medications (refer to Section 8.2 for details on prohibited medications);
12.Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
13.Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified