Phase 2 study in patient with HER2-negative inflammatory breast cancer.

Phase 1

• Conditions: Inflammatory breast cancer; MedDRA version: 20.0Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 100000020817; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001868-11-FR
• Lead Sponsor: Institut Paoli Calmettes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. 18 years or older,
2.Performance status 0 to 2,
3.Able to comply with the protocol,
4.Patient affiliated to the national Social Security” regimen or beneficiary of this regimen,
5.Patient must have signed a written informed consent form prior to any study specific screening procedures,
6.Previously untreated, histologically confirmed breast cancer and confirmed inflammatory breast cancer defined as follows:
- T4d any N following American Joint Committee on Cancer (AJCC)-7th version classification: diffuse Erythema and edema (peaud'orange) of the breast, occupying at least 1/3 of the breast, with or without underlying palpable mass
7. HER2 negative tumors by immunohistochemistry (IHC 0 or 1+) or fluores-cent/chromogenic in situ hybridization (FISH- or CISH-)
8. Hormone receptors status known,
9. No metastases,
10.Adequatehematologic function: absolute neutrophil count = 1.2 x 109/L AND platelets = 100 x 109 AND Hb = 9 g/dL,
11.Adequate liver function: total bilirubin = 1.5 ULN unless elevation is due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin AND - ASAT < 2.5 ULN AND ALAT < 2.5 ULN,
12.Adequate kidney function: serum creatinine = 1.25 ULN or creatinine clearance = 50 mL/min according to the Cockroft and Gault formula AND no proteinuria (> 1 g/24 hours),
13.Adequate cardiac function: left ventricular ejection fraction (LVEF) = 50% (isotopic or ultrasound methods),
14.International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 ULN AND normal TCA unless subject is receiving anticoagulant therapy, as long as PT or TCA is within therapeutic range of intended use of the anticoagulants,
15. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year.
Note: Abstinence is acceptable if this is the established and preferred contraception for the subject,
16. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
17. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
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. Has metastatic breast cancer,
2. Has HER2-positive breast cancer,
3. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment,
4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment,
5. Has a known history of active TB (Bacillus Tuberculosis)
6.Hypersensitivity to pembrolizumab or any of its excipients,
7. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy,
8. Has a known additional malignancy that progressed or required treatment in the last 5 years, Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer,
9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment,
10.Has history of/active pneumonitis requiring treatment with steroids or has history of/active interstitial lung disease,
11.Has an active infection requiring systemic therapy.
12.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator,
13.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial,
14.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment,
15.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent,
16.Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies),
17.Has known active Hepatitis B (e.g., HBs Ag reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected),
18.Has received a live vaccine within 30 days of planned start of study therapy.

Study & Design

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