Phase II study of PM060184 in Advanced Breast Cancer Patients in Third or Fourth Line.
- Conditions
- Breast CancerMedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002395-24-BE
- Lead Sponsor
- Pharma Mar, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
1) Voluntarily written informed consent (IC), obtained from the patient before the beginning of any specific study procedures.
2) Age = 18 years.
3) Histologically proven diagnosis of breast cancer.
4) Tumors must be hormone receptor (ER and/or PgR) positive and
HER2 negative.
5) Two or three chemotherapy lines in the advanced setting (adjuvant and/or neoadjuvant chemotherapy are allowed).
6) Previous treatment with anthracyclines and taxanes (unless clinically contraindicated for any of them).
7) Disease progression should have occurred within 2 months before study entry and within 6 months of the last administration of chemotherapy for advanced disease.
8) Measurable disease as defined by the RECIST criteria v.1.1. If the only tumor lesion is situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, progression of the lesion must be demonstrated.
9) Patients with dermic metastatic pattern only: lesions should have at least 10 mm diameter assessed by calipers and should be documented by color photography including a ruler to estimate the size of the lesion.
10) Patients with bone metastases will be eligible if other sites of
measurable disease are present.
11) Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0 or 1.
12) For patients in both arms, adequate bone marrow, liver and kidney
function:
a) Hemoglobin = 9 g/dl.
b) Neutrophil count = 1.5 × 109/l.
c) Platelet count = 100 × 109/l.
d) Serum creatinine = 1.5 mg/dl or calculated creatinine clearance = 40
ml/min.
e) Albumin = 2.5 g/dl.
f) Total serum bilirubin = 1.5 x upper limit of normal (ULN), except in
case of Gilbert´s syndrome.
g) Alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) = 3 × ULN (= 5.0 x ULN in the presence of liver metastases).
13) Peripheral neuropathy grade = 1 according to the National Cancer
Institute Common Terminology Criteria for the Classification of Adverse
Events (NCI-CTCAE) (v.4).
14) Complete recovery to grade = 1 from any toxicity due to a previous
therapy (except for alopecia) according to the NCI-CTCAE (v.4) criteria.
15) Left ventricular ejection fraction (LVEF) by echocardiography (ECHO)
or multiple-gated acquisition (MUGA) scan within normal range
(according to institutional standards).
16) At least three weeks since the last administration of chemotherapy,
biological therapy or investigational drug; six weeks since the last
administration of nitrosoureas and mitomycin C, and one week since the
last dose of hormone-therapy.
17) At least three weeks since the end of radiotherapy involving up to
35% of the bone marrow (radiotherapy involving > 35% of bone
marrow is not allowed) or two weeks since the end of palliative
radiotherapy, including single doses.
18) Life expectancy = 3 months.
19) Women of child-bearing potential must have a negative pregnancy
test seven days prior to treatment administration; a medically approved
method of contraception must be maintained while on treatment with
any of the trial medications and for six months after their last
administration. Peri-menopausal women must have had amenorrhea for
at least 12 months to be considered of non-childbearing potential.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
1) Prior exposure to PM060184.
2) Concomitant administration of any other antineoplastic therapy.
3) History of another neoplastic disease (except for prior breast cancer,
basal cell carcinoma of the skin, properly treated in situ carcinoma of
the uterine cervix, or melanoma in situ), unless in remission for five
years or longer and without local or systemic recurrence.
4) Presence of cerebral and/or leptomeningeal metastasis, even if they
are being treated.
5) Patients with locally advanced disease amenable to local therapy at
study entry.
6) Unknown HR status (both ER and PgR) and HER2 new status.
7) Inflammatory breast carcinoma.
8) Other serious and/or relevant diseases or clinical situations that, in
the Investigator´s opinion, are incompatible with the protocol (any of
the following):
a) History of cardiac disease, such as myocardial infarction, in the year
prior to enrollment in the clinical trial; symptomatic/uncontrolled angina
pectoris; congestive heart failure or uncontrolled cardiac ischemia; any
type of uncontrolled arrhythmia or abnormal left ventricular ejection
fraction, or uncontrolled arterial hypertension (according to the
standards of the World Health Organization, WHO).
b) History of significant psychiatric disease.
c) Active infection requiring antibiotic, antifungal or antiviral treatment
that, in the opinion of the Investigator, could compromise the patient´s
capacity to tolerate the therapy.
d) Known active liver (hepatitis B or C or cirrhosis) or renal disease.
e) Known human immunodeficiency virus (HIV) infection.
f) Major surgery within the two weeks prior to entering the clinical trial
or any other concomitant pathology that could jeopardize the patient´s
safety or commitment to complete the clinical trial.
9) Pregnant or breastfeeding women.
10) Inability or refusal to comply with the protocol or with the clinical
trial procedures.
11) Known hypersensitivity to PM060184 or any of the drugs to be used
in the PSPC arm (second stage).
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