Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Carboplatin

Cyclophosphamide

Albumin-Bound Paclitaxel

Epirubicin

Immunomodulating Agents

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.

12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.

Atezolizumab 840 MG in 14 ML Injection

Atezolizumab 1200 MG in 20 ML Injection

Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles

Paclitaxel 80 mg/m² IV weekly x 12 cycles

1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.

Biopsy Arm A

1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.

Biopsy Arm B

After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.

Surgery

Iris Reiser, Dr.

Hans-Christian Kolberg, Prof. Dr.

This is a randomized, open-label, adaptive, two arm, multicentre, Phase II trial comparing a neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab) and identify biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials

Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy

An Adaptive Randomized Neoadjuvant Two Arm Trial in Triple-negative Breast Cancer Comparing a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (neoMono)

Pathological Complete Response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0)

Safety (incidence, relationship, seriousness, and severity of all AEs, SAEs, AESIs coded by medical dictionary for regulatory activities (MedDRA), summarized by Preferred Term and System Organ Class and graded according to common terminology criteria of adverse events (CTCAE V5.0)

Pathological complete response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0) in patients with an ER/PR expression of \<1% and an ER/PR expression of 1% to 10%.

Pathological complete response defined as no tumor cells (invasive and no non-invasive) in the breast but also in the lymph nodes (ypN0, ypT0)

Near pCR defined as residual tumor \<5 mm in the breast irrespective of in situ and lymph nodes status

Pathological Complete Response defined as no invasive tumor in the breast, irrespective of lymph node status

Decrease of Ki-67 expression versus baseline after 14/28 days (+/- 2 days) of treatment as continuous predictor

TILs after 14/28 days (+/- 2 days) of treatment as continuous predictor

CCCA: Ki-67 expression ≤ 2.7% after 14/28 days (+/- 2 days) of treatment

Low cellularity: \< 500 tumor cells after 14/28 days (+/- 2 days) of treatment

Decrease of Ki-67 expression versus baseline by 30% or more after 14/28 days (+/- 2 days) of treatment

TILs ≥ 60% after 14/28 days (+/- 2 days) of treatment

Combined early response defined by

* CCCA (Ki-67 expression \< 2.7%) or
* low cellularity or
* decrease of Ki-67 expression (versus baseline) by 30% or more or
* TILs ≥ 60%

Disease free survival (DFS) defined as time from the first date of no disease \[i.e. date of surgery\] to the first occurrence of disease recurrence or death from any cause

Overall survival (OS) defined as length of time from randomization to death from any cause

Event free survival (EFS) defined as length of time after randomization till death from any cause, failure to achieve remission after induction therapy, relapse in any site, or second malignancy

Spots Global Cancer Trial Database for biopsy arm a

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