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Inflammatory Breast CancerPhase 2PELICANNCT03515798

Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer

A Phase 2 study testing Pembrolizumab Injection and neoadjuvant EC-paclitaxel chemotherapy in people with Inflammatory Breast Cancer, run by Institut Paoli-Calmettes at 12 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Breast Cancer
What is being tested?
Pembrolizumab Injection and neoadjuvant EC-paclitaxel chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
12 sitesFrance
Study dates
29 Aug 2018to 22 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/female participants who are at least 18 years of age on the day of signing informed consent
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Evaluation of ECOG is to be performed within 7 days prior to the date of randomization. Note: may consider ECOG PS 2 if good rationale provided and discussed with Sponsor team.
  • Able to comply with the protocol,
  • Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen, or any other regimen of social security
  • Patient (or legally acceptable representative if applicable) has provided written informed consent for the trial,
  • Previously untreated, histologically confirmed diagnosis of breast cancer and confirmed inflammatory breast cancer defined as follows:
Show all 21Show fewer
  • T4d any N following American Joint Committee on Cancer (AJCC)-8th version classification: breast erythema, edema and/or peau d'orange, occupying at least 1/3 of the breast, with or without underlying palpable mass, duration of history of no more than 6 months.
  • HER2 negative tumors by immunohistochemistry (IHC 0 or 1+) or fluorescent/chromogenic in situ hybridization (FISH- or CISH-)
  • Hormone receptors status known,
  • No metastases,
  • Have adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
  • Adequate hematologic function: absolute neutrophil count ≥ 1.5 x 109/L AND platelets ≥ 100 x 109 AND Hb ≥ 9.0 g/dL or ≥5.6 mmol/L, Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • Adequate liver function: total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AND - ASAT ≤ 2.5 ULN AND ALAT ≤ 2.5 ULN,
  • Adequate kidney function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 × institutional ULN, Creatinine clearance (CrCl) should be calculated per institutional standard.
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 ULN unless subject is receiving anticoagulant therapy, as long as PT or TCA is within therapeutic range of intended use of the anticoagulants,
  • Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% (isotopic or ultrasound methods),
  • A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 months after the last dose of cyclophosphamide and 4 months after the last dose of pembrolizumab, whichever come last.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the subject
  • A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period (corresponding to time needed to eliminate any study treatments plus an additional 120 days (a spermatogenesis cycle) for study treatments with risk of genotoxicity at any dose).

Who cannot join

  • Has metastatic breast cancer,
  • Has HER2-positive breast cancer,
  • Has bilateral breast cancer
  • Prior allogeneic stem cell or solid organ transplantation
  • A WOCBP who has a positive serum pregnancy test within 72 hours prior to randomiza-tion
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment, Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Show all 22Show fewer
  • Has known active CNS disease or carcinomatous meningitis.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug,
  • Has a known history of active TB (Bacillus Tuberculosis),
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients,
  • If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy,
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • 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 (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment,
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis,
  • Has an active infection requiring systemic therapy.
  • 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,
  • Has known psychiatric or substance abuse disorders that would interfere with coopera-tion with the requirements of the trial,
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment,
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).,
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies),
  • Has known history of Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C virus infection (e.g., HCV RNA [qualitative] is detected)
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Clinique de L'Europe

    Amiens

  • Institut Sainte Catherine

    Avignon

  • Institut BERGONIE

    Bordeaux

  • CENTRE Francois Baclesse

    Caen

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Centre Leon Berard

    Lyon

  • Institut Curie

    Paris

  • Centre Henri Becquerel

    Rouen

  • Institut Curie hopital rene huguenin

    Saint-Cloud

  • Institut de cancérologie de la loire

    Saint-Priest-en-Jarez

  • Centre Paul Strauss

    Strasbourg

  • IUCT-Oncopole Institut Claudius Rigaud

    Toulouse

Other trials in France

About this study

Official title: A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.

This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.

Read the detailed description

Inflammatory breast cancer (IBC) is a rare and highly aggressive subtype of locally advanced breast cancer representing approximately 5% of all breast cancers that requires immediate aggressive treatment. Significant progress has been made in recent years using a combination of treatments, including neoadjuvant chemotherapy, surgery and radiation therapy.

Accumulating data indicate a prognostic and/or predictive impact for immune-response variables in BC. Recent data, suggest that PD-L1 is overexpressed in a significant number of BC, notably in IBC and may have significant prognostic or predictive value. Furthermore it may be targeted to restore or boost functional antitumor immunity. Pembrolizumab, a PD-1-directed monoclonal antibody is already registered and has an out-standing activity in advanced melanoma and NSCLC patients, with promising results in several other tumor types, including triple-negative BC, and a favorable profile of tolerance.

Thus, potential benefits of pembrolizumab in combination with a conventional cytotoxic backbone may be considered as high in HER2-negative IBC.

The aim of the study is to assess the pathological complete response rate following neoadjuvant EC-paclitaxel chemotherapy plus pembrolizumab and to assess if neoadjuvant chemotherapy with anthracycline-based induction in combination with pembrolizumab exposes IBC patients to significant toxicity. rates.

Being tested
Pembrolizumab Injection, neoadjuvant EC-paclitaxel chemotherapy
Medical subject headings
Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab InjectionDrug

    Also called MK3475

    Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks

  • neoadjuvant EC-paclitaxel chemotherapyDrug

    Also called Epirubicine, Cyclophosphamide, Paclitaxel

    The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel

Study groups in NCT03515798
Study groupRoleWhat they receive
PembrolizumabExperimentalEC Paclitaxel + Pembrolizumab Injection
Receives: Drug: Pembrolizumab Injection; Drug: neoadjuvant EC-paclitaxel chemotherapy
Standard neoadjuvant chemotherapyActive comparatorEC Paclitaxel alone
Receives: Drug: neoadjuvant EC-paclitaxel chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central evaluation of pathological complete response rate

    absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)

    Measured: Following completion of neoadjuvant systemic treatment, an average of 24 weeks

  2. Dose Limiting Toxicity (DLT) rates

    incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-). DLTs will be defined according to CTCAE.

    Measured: during 21 days following the first administration of pembrolizumab

Secondary outcomes (8)

  1. occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period)

    according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0

    Measured: during 21 days following the first administration of pembrolizumab

  2. Local evaluation of pathological complete response rate

    defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)

    Measured: Following completion of neoadjuvant systemic treatment, an average of 24 weeks

  3. Invasive disease-free survival (IDFS)

    time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause

    Measured: 3 years

  4. Invasive disease-free survival (IDFS)

    time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause

    Measured: 5 years

  5. Event free survival (EFS)

    time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)

    Measured: 3 years

  6. Event free survival (EFS)

    time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)

    Measured: 5 years

  7. Overall survival (OS)

    time from randomization to death from any cause

    Measured: 3 years

  8. Overall survival (OS)

    time from randomization to death from any cause

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2018
  2. Study start29 Aug 2018
  3. Primary completion22 Aug 2022
  4. Study completion22 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03515798
Sponsor's protocol ID
PELICAN-IPC 2015-016
Other IDs
2016-001868-11, 2016
Acronym
PELICAN
Status last verified
Sep 2025
First submitted
23 Mar 2018
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.

    PubMed 28564564

  • Binder-Foucard F, Rasamimanana Cerf N, Belot A, Bossard N. Estimation nationale de l'incidence et de la mortalité par cancer en France entre 1980 et 2012. Étude à partir des registres des cancers du réseau Francim. Partie 1 - Tumeurs solides-Synthèse. In: http://www.invs.sante.fr. 2013.

  • Chang S, Parker SL, Pham T, Buzdar AU, Hursting SD. Inflammatory breast carcinoma incidence and survival: the surveillance, epidemiology, and end results program of the National Cancer Institute, 1975-1992. Cancer. 1998 Jun 15;82(12):2366-72.

    PubMed 9635529

  • Dawood S, Merajver SD, Viens P, Vermeulen PB, Swain SM, Buchholz TA, Dirix LY, Levine PH, Lucci A, Krishnamurthy S, Robertson FM, Woodward WA, Yang WT, Ueno NT, Cristofanilli M. International expert panel on inflammatory breast cancer: consensus statement for standardized diagnosis and treatment. Ann Oncol. 2011 Mar;22(3):515-523. doi: 10.1093/annonc/mdq345. Epub 2010 Jul 5.

    PubMed 20603440

  • Cristofanilli M, Valero V, Buzdar AU, Kau SW, Broglio KR, Gonzalez-Angulo AM, Sneige N, Islam R, Ueno NT, Buchholz TA, Singletary SE, Hortobagyi GN. Inflammatory breast cancer (IBC) and patterns of recurrence: understanding the biology of a unique disease. Cancer. 2007 Oct 1;110(7):1436-44. doi: 10.1002/cncr.22927.

    PubMed 17694554

  • McCarthy NJ, Yang X, Linnoila IR, Merino MJ, Hewitt SM, Parr AL, Paik S, Steinberg SM, Hartmann DP, Mourali N, Levine PH, Swain SM. Microvessel density, expression of estrogen receptor alpha, MIB-1, p53, and c-erbB-2 in inflammatory breast cancer. Clin Cancer Res. 2002 Dec;8(12):3857-62.

    PubMed 12473600

  • Lerebours F, Bieche I, Lidereau R. Update on inflammatory breast cancer. Breast Cancer Res. 2005;7(2):52-8. doi: 10.1186/bcr997. Epub 2005 Jan 20.

    PubMed 15743511

  • Chevallier B, Bastit P, Graic Y, Menard JF, Dauce JP, Julien JP, Clavier B, Kunlin A, D'Anjou J. The Centre H. Becquerel studies in inflammatory non metastatic breast cancer. Combined modality approach in 178 patients. Br J Cancer. 1993 Mar;67(3):594-601. doi: 10.1038/bjc.1993.109.

    PubMed 8439510

  • Rouesse J, Friedman S, Sarrazin D, Mouriesse H, Le Chevalier T, Arriagada R, Spielmann M, Papacharalambous A, May-Levin F. Primary chemotherapy in the treatment of inflammatory breast carcinoma: a study of 230 cases from the Institut Gustave-Roussy. J Clin Oncol. 1986 Dec;4(12):1765-71. doi: 10.1200/JCO.1986.4.12.1765.

    PubMed 3783202

  • Brun B, Otmezguine Y, Feuilhade F, Julien M, Lebourgeois JP, Calitchi E, Roucayrol AM, Ganem G, Huart J, Pierquin B. Treatment of inflammatory breast cancer with combination chemotherapy and mastectomy versus breast conservation. Cancer. 1988 Mar 15;61(6):1096-103. doi: 10.1002/1097-0142(19880315)61:63.0.co;2-y.

    PubMed 3342369

  • Jaiyesimi IA, Buzdar AU, Hortobagyi G. Inflammatory breast cancer: a review. J Clin Oncol. 1992 Jun;10(6):1014-24. doi: 10.1200/JCO.1992.10.6.1014.

    PubMed 1588366

  • Cristofanilli M, Buzdar AU, Sneige N, Smith T, Wasaff B, Ibrahim N, Booser D, Rivera E, Murray JL, Valero V, Ueno N, Singletary ES, Hunt K, Strom E, McNeese M, Stelling C, Hortobagyi GN. Paclitaxel in the multimodality treatment for inflammatory breast carcinoma. Cancer. 2001 Oct 1;92(7):1775-82. doi: 10.1002/1097-0142(20011001)92:73.0.co;2-e.

    PubMed 11745249

  • Cristofanilli M, Gonzalez-Angulo AM, Buzdar AU, Kau SW, Frye DK, Hortobagyi GN. Paclitaxel improves the prognosis in estrogen receptor negative inflammatory breast cancer: the M. D. Anderson Cancer Center experience. Clin Breast Cancer. 2004 Feb;4(6):415-9. doi: 10.3816/cbc.2004.n.004.

    PubMed 15023242

  • de Matteis A, Nuzzo F, D'Aiuto G, Labonia V, Landi G, Rossi E, Mastro AA, Botti G, De Maio E, Perrone F. Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast: a single-center, phase II study. Cancer. 2002 Feb 15;94(4):895-901. doi: 10.1002/cncr.20335.abs.

    PubMed 11920456

  • Gradishar WJ, Wedam SB, Jahanzeb M, Erban J, Limentani SA, Tsai KT, Olsen SR, Swain SM. Neoadjuvant docetaxel followed by adjuvant doxorubicin and cyclophosphamide in patients with stage III breast cancer. Ann Oncol. 2005 Aug;16(8):1297-304. doi: 10.1093/annonc/mdi254. Epub 2005 May 19.

    PubMed 15905305

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab Injection and neoadjuvant EC-paclitaxel chemotherapy in people with Inflammatory Breast Cancer, run by Institut Paoli-Calmettes at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central evaluation of pathological complete response rate (time frame: Following completion of neoadjuvant systemic treatment, an average of 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03515798, which also lists 72 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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