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Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorBlokhin's Russian Cancer Research Center

About this trial

To explore the application of Camrelizumab with chemotherapy as neoadjuvant treatment of early-stage TNBC. Phase II clinical study of Camrelizumab in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Camrelizumab and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment;

Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies;

Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;

Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus;;

Trial design

Design model

Single group

Treatments tested in this trial

  • Camrelizumab

    Drug

    200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 10 times

  • Doxorubicin +cyclophosphamide+ filgrastimum

    Drug

    Doxorubicin 60mg/m² + cyclophosphamide 600 mg/m² on Day 1 of Cycles 1-4 (Q2W) of the first neoadjuvant phase of the study, IV infusion. filgrastim (G-CSF) subcutaneously on days 2-6 of Cycles 1-4

  • carboplatin + paclitaxel (CP)

    Drug

    carboplatin AUC 2 and paclitacel 80 mg/m² will be given on day 1 every 12 weeks of the second neoadjuvant phase of the study, IV infusion.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: neadjuvant chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response (pCR)

Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).

Time frame
The outcome was changed from 19 weeks at the time of results entry as the treatment period was actually 20 weeks and the outcome was assessed 4-6 weeks after treatment when surgery took place.

Secondary outcomes

1

objective response rate (ORR)

Time frame
average 18 months
2

Disease-free Survival

Defined as the time between Day 1 Cycle 1 to breast cancer progression

Time frame
expected average 48 months
3

Overall Survival

Defined as the time between Day 1 Cycle 1 to date of death from any cause

Time frame
approximately 48 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blokhin's Russian Cancer Research Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: