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 stage IV oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinomaMedDRA version: 20.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000020826Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002541-63-FR
- Lead Sponsor
- Immutep S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 211
1. Able to give written informed consent and to comply with the protocol
2. Stage IV 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. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug. Patients must be either,
- not of childbearing potential: postmenopausal (= 60 years of age, or < 60 years of age and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with follicle-stimulating 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., tubal occlusion, hysterectomy, bilateral salpingectomy), or otherwise be incapable of pregnancy
- of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for patients participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that patient); true abstinence (when this is in line with the preferred and usual lifestyle of the patient)
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. 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 mmol/L, except for familial cholemia (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 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
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. Inflammatory carcinoma
5. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
6. Systemic chemotherapy, endocrine therapy, or any other investigational agent within 4 weeks prior to first dose of study treatment and until completion of study treatment
7. Known cerebral 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. 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 of any grade, 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. Known HIV positivity
16. History of Hepatitis B or C exposure, currently controlled by antiviral therapy
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. Participation in another clinical study within 4 weeks prior to screening
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
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