Breast CancerPhase 2NCT03742986
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
A Phase 2 study testing Nivolumab 360mg, Paclitaxel 80mg/m^2 and Doxorubicin 60mg/m^2 in people with Breast Cancer, run by NYU Langone Health at 2 sites in United States.
Trial summary
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nivolumab 360mg, Paclitaxel 80mg/m^2 and Doxorubicin 60mg/m^2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2019to 12 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive
Who cannot join
- Clinical or radiologic evidence of distant metastases
- Malignancy that progressed within the last five years.
- Cardiac disease (history of and/or active disease)
- HIV positive
- Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
- Allogeneic stem cell or solid organ transplantation
Show all 16Show fewer
- Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis
- Tuberculosis
- Pregnancy or lactation
- Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunosuppressive medications
- Cardiopulmonary dysfunction
- Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C
- Subject is pregnant or nursing
- Known hypersensitivity to the components of the study drugs(s)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Bloomington, Indiana, 47405
NYU Langone Health
New York, New York, 10016
About this study
Official title: Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Read the detailed description
The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).
- Conditions
- Breast Cancer
- Being tested
- Nivolumab 360mg, Paclitaxel 80mg/m^2, Doxorubicin 60mg/m^2, Cyclophosphamide 600mg/m^2, Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
- Keywords
- Nivolumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 360mgDrug
Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m^2Drug
Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m^2Drug
Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m^2Drug
Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2Drug
Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kgDrug
Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mgDrug
Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
| Study group | Role | What they receive |
|---|---|---|
| HER2-negative, including TNBC or HR-positive | Experimental | Not described Receives: Drug: Nivolumab 360mg; Drug: Paclitaxel 80mg/m^2; Drug: Doxorubicin 60mg/m^2; Drug: Cyclophosphamide 600mg/m^2 |
| HER2-positive, independent of HR status | Experimental | Not described Receives: Drug: Nivolumab 360mg; Drug: Doxorubicin 60mg/m^2; Drug: Cyclophosphamide 600mg/m^2; Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2; Drug: Trastuzumab 8mg/kg and 6 mg/kg; Drug: Pertuzumab 840mg and 420mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Measured: up to 16 weeks
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start2 May 2019
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryann Kwa, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742986
- Sponsor's protocol ID
- 17-00890
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2018
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
- ClinicalTrials.gov ID
- NCT03742986
- Acronym / sponsor ID
- 17-00890
- Conditions
- Breast Cancer
- Keywords
- Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 25 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Detailed description
The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-negative, including TNBC or HR-positive | Experimental | Drug: Nivolumab 360mg, Drug: Paclitaxel 80mg/m^2, Drug: Doxorubicin 60mg/m^2, Drug: Cyclophosphamide 600mg/m^2 |
| HER2-positive, independent of HR status | Experimental | Drug: Nivolumab 360mg, Drug: Doxorubicin 60mg/m^2, Drug: Cyclophosphamide 600mg/m^2, Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2, Drug: Trastuzumab 8mg/kg and 6 mg/kg, Drug: Pertuzumab 840mg and 420mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive
Key exclusion criteria (16 listed)
- Clinical or radiologic evidence of distant metastases
- Malignancy that progressed within the last five years.
- Cardiac disease (history of and/or active disease)
- HIV positive
- Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab 360mgNivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4) | Drug | HER2-negative, including TNBC or HR-positive, HER2-positive, independent of HR status |
| Paclitaxel 80mg/m^2Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4) | Drug | HER2-negative, including TNBC or HR-positive |
| Doxorubicin 60mg/m^2Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8) | Drug | HER2-negative, including TNBC or HR-positive, HER2-positive, independent of HR status |
| Cyclophosphamide 600mg/m^2Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8) | Drug | HER2-negative, including TNBC or HR-positive, HER2-positive, independent of HR status |
| Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4) | Drug | HER2-positive, independent of HR status |
| Trastuzumab 8mg/kg and 6 mg/kgTrastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4 | Drug | HER2-positive, independent of HR status |
| Pertuzumab 840mg and 420mgPertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4 | Drug | HER2-positive, independent of HR status |
Primary outcome
Number of Participants Who Had a Pathological Complete Response (pCR)
Time frame: up to 16 weeks
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Number of Participants Who Had a Pathological Complete Response (pCR)
Time frame: up to 1 year
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryann Kwa principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab 360mg, Paclitaxel 80mg/m^2 and Doxorubicin 60mg/m^2 in people with Breast Cancer, run by NYU Langone Health at 2 sites in United States.
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 1 inclusion and 16 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: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had a Pathological Complete Response (pCR) (time frame: up to 16 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?
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 19 Dec 2023.