Data

A phase II study evaluating efficacy and safety of Ipilimumab and Nivolumab with neoadjuvant weekly paclitaxel after anthracycline based chemotherapy in high-risk primary triple negative breast cancer, followed by definitive surgery and one year total duration of Nivolumab (BCT 1702 CHARIOT)

Breast Cancer Trials (BCT)

Dataset description

* Dataset of 34 patients with high risk primary triple negative breast cancer suitable for neoadjuvant treatment after treatment with 4 cycles anthracycline-based chemotherapy. * Study treatment for 12 weeks with Nivolumab for 6 doses; Ipilimumab for 2 doses; paclitaxel weekly for 12 doses. * Surgery withn 4 weeks of last paclitaxel dose. * Followed by nivolumab every 4 weeks for up to 1 year. * Survival follow up at 24 months and 36 months from cycle 1 day 1. * pCR, residual diseae, objective response rate data. * Safety/toxicity, event free survival, overall survival data. * ctDNA data.
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Source Study

Funding

Other Collaborative groups,Breast Cancer Trials

Scientific enquiries

A/Prof Sherene Loi

Brief Summary

This study aims to find out if treatment with a combination of Ipilimumab and Nivolumab, with weekly paclitaxel before surgery, and treatment with Nivolumab after surgery, is safe and effective in women and men diagnosed with triple negative breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older, have been diagnosed with triple negative breast cancer, will be having neoadjuvant treatment (treatment with anthracycline-based chemotherapy before surgery) and y ....
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Key Inclusion Criteria

For inclusion in the study, participants must fulfil all of the following criteria: 1) Female or male, age >= 18 years. 2) Non-metastatic, potentially operable, unilateral triple negative breast cancer, histologically defined as: a) ER negative: with < 1% of tumour cells positive for ER by IHC irrespective of staining intensity; AND b) PR negative: with < 1% tumour cells positive for PR by IHC irrespective of staining intensity; AND c) HER2 negative: i) IHC 1+, as defined by incomplete membrane ....
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Key Exclusion Criteria

Any one of the following is regarded as a criterion for exclusion from the study: 1) Has evidence of metastatic breast cancer or concurrent bilateral invasive breast cancer. Staging must be performed as clinically appropriate. Biopsies should be performed to confirm or exclude metastatic disease if possible. 2) Inoperable breast cancer at completion of 4 cycles of anthracycline-based chemotherapy. 3) Patients planned to receive neoadjuvant breast radiation therapy 4) Has received prior chemother ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    34

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Primary triple negative breast cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

Before surgery, participants will receive the following treatment simultaneously over a 12 week period: * Nivolumab intravenously at 240 mg every 2 weeks for 6 doses; * Ipilimumab intravenously at 1mg/kg every 6 weeks for 2 doses; * Paclitaxel intravenously at 80 mg/m^2 weekly for 12 doses. Where administration of the study drugs happens on the same day, nivolumab is administered first, ipilimumab is administered 30 minutes after nivolumab, and paclitaxel is administered last. Study treatment is ....
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Comparison

Control group Uncontrolled

None

Outcomes

Outcome: The rate of pathological complete response (pCR) in the breast and axilla as defined by no histologic evidence of residual invasive cancer cells on haematoxylin and eosin (H&E) evaluation of the resected breast and lymph node specimens.
Timepoint: Definitive surgery.

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Anonymised Individual Patient Data (IPD) collected during the trial. The specific IPD to be shared (e.g. all data, published data, data of primary outcomes) will be as per the submitted research proposal and as assessed as appropriate by BCT.

When will data be available?

Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.

Available to whom?

Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines.

Available for what types of analyses?

To achieve the aims in the approved proposal.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au