A study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.
- Conditions
- Female metastasized oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinomaMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2015-002541-63-NL
- Lead Sponsor
- Immutep S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 241
1. Able to give written informed consent and to comply with the protocol
2.1 Metastasized oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis
3. Female of age 18 years or above
4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel
5.1 All patients of childbearing potential must have a negative highly sensitive pregnancy test at screening and agree to use highly effective method for contraception according to the EU Clinical Trial Facilitation Group guidance from time of study entry until at least 6 months after the last administration of study drug. The partners of patients with childbearing potential must also apply
contraceptive methods. Patients who are either ,
o postmenopausal (= 60 years of age, or < 60 years of age and amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with folliclestimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L; or if taking tamoxifen or toremifene, and age < 60 years, then FSH and oestradiol in the postmenopausal range), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy),
o or otherwise be incapable of pregnancy are not considered to be of childbearing potential
6. ECOG performance status 0-1
7. Expected survival longer than three months
8. Resolution of toxicity of prior therapy to grade < 2 (except for alopecia and transaminases in case of liver metastases)
9. Evidence of measurable disease as defined by RECIST version 1.1
10.1 Laboratory criteria:
? Total white cell count = 3 x 10^9/L
? Platelet count = 100 x 10^9/L
? Haemoglobin = 9 g/dL or 5.58 mmol/L
? Absolute Neutrophil Count (ANC) = 1.5 x 10^9/L
? Serum creatinine = 1.5 × ULN
? Total bilirubin = 20 µmol/L, except for familial cholaemia (Gilbert’s disease)
? Serum ASAT and ALAT = 3 times ULN or = 5 times ULN if liver metastases are present
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 121
1. Prior chemotherapy for metastatic breast adenocarcinoma
2. Disease-free interval of less than twelve months from the last dose of
adjuvant chemotherapy
3. Prior high-dose chemotherapy requiring hematopoietic stem cell
rescue
4.1 Inflammatory carcinoma at time of screening
5.1 Candidate for treatment with trastuzumab (or other Her2/neu
targeted agents) or endocrine based therapy according to the applicable
treatment guidelines
6.2 Systemic chemotherapy, radiation therapy or any other
investigational agent within 4 weeks, endocrine therapy within 1 week
or CDK4/6 inhibitors within 5 times half-life (acc. to SPC) prior to first
dose of study treatment
7.1 Symptomatic known cerebral and/or leptomeningeal metastases
8. Women who are pregnant or lactating
9. Serious intercurrent infection within 4 weeks prior to first dose of
study treatment
10. QTcF >480 ms, family or personal history of long or short QT
syndrome, Brugada syndrome or known history of QTc prolongation, or
Torsade de Pointes (TdP)
11. Uncontrolled electrolyte disorders that can worsen the effects of a
QTc-prolonging drug (e.g., hypocalcaemia, hypokalaemia,
hypomagnesemia)
12.1 Evidence of severe or uncontrolled cardiac disease (NYHA III-IV)
within 6 months prior to first dose of study treatment including:
myocardial infarction, severe/unstable angina, ongoing cardiac
dysrhythmias of NCI CTCAE version 4.03 Grade =2, atrial fibrillation ,
coronary/peripheral artery bypass graft, symptomatic congestive heart
failure, cerebrovascular accident including transient ischemic attack,
ventricular arrhythmias requiring medication or symptomatic pulmonary
embolism
13. Active acute or chronic infection
14. Active autoimmune disease requiring immunosuppressive therapy
15.1 Positive test for HIV
16.1 Positive test for Hepatitis B (anti–HBc) or C (Patients who are anti-
HBc+ and HBsAg negative are eligible and are not excluded from
participation in this study)
17. Life threatening illness unrelated to cancer
18. Previous malignancies within the last three years other than breast
carcinoma, except successfully treated squamous cell carcinoma of the
skin, superficial bladder cancer, and in situ carcinoma of the cervix
19. Any current disorder that would impede the patient's ability to
provide informed consent or to comply with the protocol
20. Any condition requiring continuous systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalents) or other
immunosuppressive medications within 4 weeks prior to first dose of
study treatment. Inhaled or topical steroids and physiological
replacement doses of up to 10 mg daily prednisone equivalent are
permitted in the absence of active autoimmune disease
21. Past history of severe allergic episodes and/ or Quincke's oedema
22. Alcohol or substance abuse disorder
23. Known hypersensitivity to any of the components of the study agents
24.1 Participation in an interventional clinical study within 4 weeks prior
to first dose of study treatment, with intervention not covered by
exclusion criterion 6.2
25. Unwilling or unable to follow protocol requirements
26. In the clinical judgment of the Investigator, the patient is unsuitable
for participation in this study
27. Persons with any kind of dependency on the Investigator or
employed by the sponsor or Investigator
28. Persons held in an institution by legal or official order
29. Patients with prior organ or stem cell transplantation
30. Patients having received a live, attenuated vacci
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