Clinical Trial Application for a Phase II study in patients with hormone receptor positive breast cancer with bortezomib (Velcade) in the reversal of endocrine resistance. - the HoBo Study

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

• Registration Number: EUCTR2006-004144-23-BE
• Lead Sponsor: AZ St Augustinus, Wilrijk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

1)Female adult (> 18 years) patients with metastatic breast cancer,
2)Postmenopausal status defined as either
a. > 55 years
b.bilateral ovariectomy
c.< 55 years with menopausal FSH levels
d.patients on LH-RH agonists in combination with either SERM or AI must continue the LHRH agonist,
3)ER and/or PgR + disease (at least 10% of nuclei in the initial are either ER or PgR positive) as defined in the participating institution,
4)Measurable disease by RECIST,
5)All patients should have been treated either in the adjuvant or metastatic setting with tamoxifen and an AI,
6)Radiologically documented disease progression of disease as defined by RECIST criteria after second line (if prior adjuvant endocrine treatment and relapse within 12 months of stopping this treatment, this can be considered a resistance to this agent) endocrine treatment for metastatic disease being either tamoxifen or any aromatase inhibitor (AI), with patients still considered to be suitable candidates for a third line endocrine treatment,
7)Superficial measurable lesions will be included as measurable, provided it is photographed,
8)Patients need to be on this endocrine treatment for at least three months in order to clearly document endocrine resistance and exclude as much as possible late responses,
9)Disease progression has to documented on consecutive radiological examinations or photographs (excluding ultrasound and PET),
10)Adequate bone marrow reserve WCC > 3.0x109/L, ANC > 1.5x109/L, PLTs> 100x109/L, Hb >10gr/dL,
11)Normal liver function defined by a bilirubin < 1.25 x ULN and transaminases < 3 x ULN,
12)Life expectancy > 6 months,
13) One line of chemotherapy for metastatic disease is allowed provided this was not the last treatment received prior to study entry,
14) No peripheral neuropathy > grade 1,
15) No other life-threatening 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Non-measurable disease as sole disease sites as defined by RECIST,
2)More than one line of chemotherapy for metastatic disease,
3)Prior radiotherapy within two weeks prior to study entry,
4)Surgery within two weeks prior to study entry,
5)Other invasive cancer diagnosis within 5 years prior to study entry,
6)Severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis,
7)Uncontrolled diabetes mellitus, (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug,
8)Pregnant or breast feeding,
9)Neuropathy > or = grade II,
10)Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
11) Serious medical or psychiatric conditions that precludes participation in this study.

Study & Design

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