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AzTrials

Triple-negative Breast CancerPhase 2neoMonoNCT04770272

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

A Phase 2 study testing Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection and Carboplatin in people with Triple-negative Breast Cancer, run by Palleos Healthcare GmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
442 participants
Where
1 siteGermany
Study dates
1 Mar 2021to 2 Oct 2024
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

  • Female and male patients, age at diagnosis 18 years and above
  • Written informed consent prior to admission to this study
  • Histologically confirmed unilateral primary invasive carcinoma of the breast
  • Clinical T1c - T4d
  • Stage N0-N3 until 21 patients (5%) with stage N3 are randomized, thereafter N0-N2
  • Triple negative breast cancer defined by and confirmed by central pathology:
Show all 37Show fewer
  • ER negative (<10% positive cells in IHC) and PR negative (<10% positive cells on IHC)
  • HER2 negative breast cancer:
  • Either defined by IHC: ICH scores of 0-1 or an ICH score of 2 in combination with a negative in-situ-hybridization (ISH)
  • Or defined by ISH: negative ISH
  • Identifiable PD-L1 IC-status by central pathology (positive or negative) by means of VENTANA PD-L1 (SP142) assay; positive status is defined by PD-L1 expression on IC on ≥ 1% of the tumor area, negative status is defined by PD-L1 expression on IC on < 1% of the tumor area
  • No clinical evidence for distant metastasis (cM0)
  • Tumor block available for translational research
  • Performance Status Eastern Cooperative Oncology Group (ECOG) ≤ 1 or KI ≥ 80 %
  • Negative pregnancy test (urine or serum) within 7 days prior to screening in premenopausal patients
  • Women of childbearing potential and male patients with partners of childbearing potential must accept to implement a highly effective (less than 1% failure rate according to Pearl index) including at least one non-hormonal contraceptive measures during the study treatment and for 5 months following the last dose of study treatment such as:
  • Intrauterine device (IUD)
  • bilateral tubal occlusion
  • vasectomized partner
  • sexual abstinence
  • The patient must be accessible for treatment and follow-up
  • Normal cardiac function:
  • Normal electrocardiogram (ECG) (within 6 weeks prior to screening)
  • Normal left ventricular ejection fraction (LVEF) on echocardiorgraphy
  • Normal thyroid function
  • o Normal TSH and FT4
  • Blood counts within 14 days prior screening:
  • absolute neutrophile count (ANC) must be ≥ 1,500/mm3
  • Platelet count must be ≥ 100,000 / mm3
  • Hemoglobin must be ≥ 10 g/dl
  • Hepatic functions:
  • Total bilirubin must be ≤ 1 upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > 1 x ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin
  • Alkaline phosphatase must be ≤ 2.5 x ULN for the lab
  • AST and ALT must be ≤1.5 x ULN for the lab.
  • Patients with AST and ALT or alkaline phosphatase > 1 x ULN are eligible for inclusion if liver imaging (computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET-CT, or PET scan) performed within 3 months prior to randomization (and part of standard of care) does not demonstrate metastatic disease and the requirements in criterion (just above) are met
  • Patients with alkaline phosphatase that is > 1 x ULN but less than or equal to 2.5 x ULN or with unexplained bone pain are eligible if bone imaging does not demonstrate metastatic disease.
  • Creatinine clearance ≥ 40 ml/min performed 28 days prior to screening

Who cannot join

  • Previous history of malign diseases, non-melanoma skin cancer and carcinoma of the cervix are allowed if treated with curative intent
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of Paclitaxel, Carboplatin, Epirubicin, Cyclophosphamide or Atezolizumab
  • Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol
  • Concurrent treatment with other drugs that are contraindicating the use of the study drugs
  • Existing pregnancy
  • Breastfeeding
Show all 38Show fewer
  • Sequential breast cancer
  • Concurrent treatment with other experimental drugs and participation in another clinical trial or clinical research project (except registry study) within 30 days prior to study entry
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including but not confined to:
  • Uncompensated chronic heart failure or systolic dysfunction (LVEF < 55%, congestive heart failure (CHF) New York Heart Association (NYHA) classes II-IV),
  • unstable arrhythmias requiring treatment i.e., atrial tachycardia with a heart rate ≥ 100/bpm at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher grade AV-block,
  • Angina pectoris within the last 6 months requiring anti-anginal medication,
  • Clinically significant valvular heart disease,
  • Evidence of myocardial infarction on electrocardiogram (ECG),
  • Poorly controlled hypertension (e.g., systolic > 180 mmHg or diastolic > 100 mmHg).
  • Inadequate organ function including but not confined to:
  • hepatic impairment as defined by bilirubin > 1.5 x ULN
  • pulmonary disease (severe dyspnea at rest requiring oxygen therapy)
  • Abnormal blood values:
  • Platelet count below 100,000/mm3
  • AST/ALT > 1.5 x ULN
  • Hypokalaemia > CTCAE grade 1
  • Neutropenia > CTCAE grade 1
  • Anaemia > CTCAE grade 1
  • Administration of a live, attenuated vaccine within 4 weeks before cycle 1 day 1 or anticipation that such a vaccine will be required during the study
  • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization.
  • Treatment with systemic immunosuppressive medications (including but not limited to Prednisone, Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to screening or anticipation of need for systemic immunosuppressive medications during the study
  • Patients with prior allogeneic stem cell or solid organ transplantation
  • Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
  • Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are permitted provided all of following conditions are met: Rash must cover < 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, Methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral Corticosteroids within the previous 12 months.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • History of HIV infection, hepatitis B or hepatitis C infection.
  • Patients with significant cardiovascular disease
  • Patients with inadequate hematological and end-organ function
  • Patients receiving therapeutic anti-coagulants
  • Stage N3, as soon as 21 patients with stage N3 are randomized

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe;

    Bottrop, 46236

Other trials in Germany

About this study

Official title: 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)

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

Read the detailed description

This is a randomized, open-label, adaptive, two arm, multicenter phase II trial that enrolled female and male patients with primary TNBC (defined as ER/PR < 10% and HER2-negative) with tumor stages cT1c - cT4d (cN0 and cN+). Patients are randomized to Arm A and B. Randomization is stratified by PD-L1 expression on immune cells (IC-status) and anatomic tumor stage (according to the AJCC 8th edition Anatomic Stage Groups I, II andIII). PD-L1 status is determined by central pathology using the VENTANA PD-L1 (SP142) assay and is defined by PD-L1 IC expression.

Patients in Arm A receive a 2-week monotherapy of Atezolizumab 840 mg q2w prior to initiation of a 12-week neoadjuvant CTX therapy with Paclitaxel 80 mg/m2 i.v. q1w x 12 doses + Carboplatin AUC of 2 i.v. q1w x 12 doses + Atezolizumab 1200 mg day 1 every 3 weeks for 4 doses followed by Epirubicin 90 mg/m2 + Cyclophosphamide 600 mg/m2, both q3w for 4 cycles + Atezolizumab 1200 mg day 1 every 3 weeks for 4 doses.

Patients in Arm B are treated with a neoadjuvant 12-week regimen of Paclitaxel 80 mg/m² i.v. q1w x 12 doses + Carboplatin AUC of 2 i.v. q1w x 12 doses + Atezolizumab 1200 mg day 1 every 3 weeks for 4 doses without a monotherapy window. This is followed by Epirubicin 90 mg/m² + Cyclophosphamide 600 mg/m2, both q3w for 4 cycles + Atezolizumab 1200 mg day 1 every 3 weeks for 4 doses.

Patients in both arms undergo surgery after 29 - 30 weeks therapy in total for Arm A and 27 - 28 weeks therapy in total for Arm B (3 - 4 weeks after last dose of neoadjuvant therapy).

Safety and toxicities under therapy are supervised via regular DSMB meetings. After surgery, patients are treated according to the local SoC therapy for TNBC and followed-up for 24 months.

Being tested
Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection, Carboplatin, Paclitaxel, Epirubicin
Keywords
TNBC, Immunotherapy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • Atezolizumab 840 MG in 14 ML InjectionDrug

    Also called Tecentriq

    840 mg Day 1 for two weeks

  • Atezolizumab 1200 MG in 20 ML InjectionDrug

    Also called Tecentriq

    1200 mg Day 1 every 3 weeks for 8 cycles

  • CarboplatinDrug

    Also called Paraplatin

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

  • PaclitaxelDrug

    Also called Abraxane, Onxol

    Paclitaxel 80 mg/m² IV weekly x 12 cycles

  • EpirubicinDrug

    Also called Paxene

    90 mg/m2, day 1 for 4 cycles (12 weeks)

  • CyclophosphamideDrug

    Also called Cytoxan

    600 mg/m2, day 1 for 4 cycles (12 weeks)

  • Biopsy Arm AProcedure or surgery

    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 BProcedure or surgery

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

  • SurgeryProcedure or surgery

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

Study groups in NCT04770272
Study groupRoleWhat they receive
Arm AExperimental2 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.
Receives: Drug: Atezolizumab 840 MG in 14 ML Injection; Drug: Atezolizumab 1200 MG in 20 ML Injection; Drug: Carboplatin; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Procedure: Biopsy Arm A; Procedure: Surgery
Arm BActive comparator12-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.
Receives: Drug: Atezolizumab 1200 MG in 20 ML Injection; Drug: Carboplatin; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Procedure: Biopsy Arm B; Procedure: Surgery

What is being measured

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

  1. Pathological Complete Response (ypT0/is, ypN0)

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

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.

Secondary outcomes (19)

  1. Number of Adverse Events by Grade

    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)

    Measured: from date of randomization up to 24 months

  2. Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%).

    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%.

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B

  3. Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %).

    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%.

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B

  4. Pathological Complete Response (ypT0, ypN0)

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

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.

  5. Near Pathological Complete Response (Near pCR)

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

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.

  6. Pathological Complete Response (no Invasive Tumor)

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

    Measured: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.

  7. Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment

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

    General comment to analysis of secondary biomarker endpoints: biomarker endpoints are analysed as secondary efficacy endpoints. Biomarker endpoints are measured by core biopsy at a central pathology laboratory at two different timepoints. For arm A visit 1 (A1 in tables) corresponds to day 14 in the trial and denotes the measurement after the Atezolizumab monotherapy window. Arm A visit 3 (A3 in tables) corresponds to day 28 and denotes a measurement taken again after two weeks of combined immuno- and chemotherapy. In arm B, only visit 2 (day 14; B2 in tables) is measured after the initial two weeks of combined immuno- and chemotherapy.

    Measured: after 14/28 days (+/- 2 days) of treatment

  8. Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B.

    Decrease of Ki-67 expression versus baseline by 30% or more after 28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above. Decrease of Ki-67 defined as ≥ 30% compared to baseline.

    Measured: after 28 days (+/- 2 days) of treatment

  9. Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB)

    TILs after 14/28 days (+/- 2 days) of treatment as continuous predictor. See general comments to biomarker endpoints above.

    Measured: after 14/28 days (+/- 2 days) of treatment

  10. Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 28 Days

    TILs ≥ 60% after 28 days (+/- 2 days) of treatment. Stromal Tumor Infiltrating Lymphocytes (TILs) ≥ 60%.

    See general comments to biomarker endpoints above.

    Measured: after 28 days (+/- 2 days) of treatment

  11. Complete Cell Cycle Arrest (CCCA) After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment

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

    See general comments to biomarker endpoints above.

    Measured: after 14/28 days (+/- 2 days) of treatment

  12. Complete Cell Cycle Arrest (CCCA) After 28 Days (+/- 2 Days) of Treatment

    CCCA: Ki-67 expression ≤ 2.7%. Complete Cell Cycle Arrest (CCCA) defined as : Ki-67 ≤ 2.7%.

    See general comments to biomarker endpoints above.

    Measured: after 28 days (+/- 2 days) of treatment

  13. Low Cellularity (< 500 Tumor Cells) After 14 (Arm A)/28 Days (Arm B) (+/- 2 Days) of Treatment

    Low cellularity: < 500 tumor cells after 14/28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.

    Measured: after 14/28 days (+/- 2 days) of treatment

  14. Low Cellularity (< 500 Tumor Cells) After 28 Days (+/- 2 Days) of Treatment

    Low cellularity: < 500 tumor cells after 28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.

    Measured: after 28 days (+/- 2 days) of treatment

  15. Combined Early Response After 14 (Arm A)/28 (Arm B) 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% See general comments to biomarker endpoints above.

    Measured: after 14/28 days (+/- 2 days) of treatment

  16. Combined Early Response After 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% See general comments to biomarker endpoints above.

    Measured: after 28 days (+/- 2 days) of treatment

  17. Disease Free Survival (DFS)

    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.

    Measured: from randomization up to 24 months until date of occurrence of no disease to the first occurrence of disease recurrence or death from any cause

  18. Overall Survival (OS).

    Overall survival (OS) defined as length of time from randomization to death from any cause. Given that novel post-neoadjuvant treatment options (on and off-trial) have emerged such as Pembrolizumab, the post-neoadjuvant treatment in the follow-up phase of this study would have been most certainly highly heterogeneous. Thus, completion of follow-up to 3 years was no longer justified. Therefore, follow-up was limited to 2 years and only clinically significant survival signals were observed.

    Measured: from randomization up to 24 months until date of death from any cause.

  19. Event Free Survival (EFS)

    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

    Measured: from randomization up to 24 months until date of death from any cause, failure to achieve remission after induction therapy, relapse in any site, or second malignancy

Timeline

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

  1. First posted25 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion6 Jul 2023
  4. Study completion2 Oct 2024

Why it stopped: The trial stopped recruitment prematurely after a first planned interim analysis of the first 100 pCR results (given that a probability of less than 2.5% of meeting the primary endpoint was 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
442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04770272
Sponsor's protocol ID
Phaon1
Acronym
neoMono
Status last verified
Dec 2025
First submitted
18 Feb 2021
Last updated
12 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alme AK, Karir BS, Faltas BM, Drake CG. Blocking immune checkpoints in prostate, kidney, and urothelial cancer: An overview. Urol Oncol. 2016 Apr;34(4):171-81. doi: 10.1016/j.urolonc.2016.01.006. Epub 2016 Feb 28.

    PubMed 26923782

  • Bauer KR, Brown M, Cress RD, Parise CA, Caggiano V. Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry. Cancer. 2007 May 1;109(9):1721-8. doi: 10.1002/cncr.22618.

    PubMed 17387718

  • Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

    PubMed 24529560

  • Crittenden M, Kohrt H, Levy R, Jones J, Camphausen K, Dicker A, Demaria S, Formenti S. Current clinical trials testing combinations of immunotherapy and radiation. Semin Radiat Oncol. 2015 Jan;25(1):54-64. doi: 10.1016/j.semradonc.2014.07.003.

    PubMed 25481267

  • Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.

    PubMed 17671126

  • Deyarmin B, Kane JL, Valente AL, van Laar R, Gallagher C, Shriver CD, Ellsworth RE. Effect of ASCO/CAP guidelines for determining ER status on molecular subtype. Ann Surg Oncol. 2013 Jan;20(1):87-93. doi: 10.1245/s10434-012-2588-8. Epub 2012 Aug 9.

    PubMed 22875649

  • Ditsch N, Untch M, Thill M, Muller V, Janni W, Albert US, Bauerfeind I, Blohmer J, Budach W, Dall P, Diel I, Fasching PA, Fehm T, Friedrich M, Gerber B, Hanf V, Harbeck N, Huober J, Jackisch C, Kolberg-Liedtke C, Kreipe HH, Krug D, Kuhn T, Kummel S, Loibl S, Luftner D, Lux MP, Maass N, Mobus V, Muller-Schimpfle M, Mundhenke C, Nitz U, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schutz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Wenz F, Witzel I, Wockel A. AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2019. Breast Care (Basel). 2019 Aug;14(4):224-245. doi: 10.1159/000501000. Epub 2019 Aug 6. No abstract available.

    PubMed 31558897

  • Dixon JM, Cameron DA, Arthur LM, Axelrod DM, Renshaw L, Thomas JS, Turnbull A, Young O, Loman CA, Jakubowski D, Baehner FL, Singh B. Accurate Estrogen Receptor Quantification in Patients with Negative and Low-Positive Estrogen-Receptor-Expressing Breast Tumors: Sub-Analyses of Data from Two Clinical Studies. Adv Ther. 2019 Apr;36(4):828-841. doi: 10.1007/s12325-019-0896-0. Epub 2019 Mar 11.

    PubMed 30859501

  • Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G; IMPACT Trialists. Short-term changes in Ki-67 during neoadjuvant treatment of primary breast cancer with anastrozole or tamoxifen alone or combined correlate with recurrence-free survival. Clin Cancer Res. 2005 Jan 15;11(2 Pt 2):951s-8s.

    PubMed 15701892

  • Dowsett M, Smith I, Robertson J, Robison L, Pinhel I, Johnson L, Salter J, Dunbier A, Anderson H, Ghazoui Z, Skene T, Evans A, A'Hern R, Iskender A, Wilcox M, Bliss J. Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer. J Natl Cancer Inst Monogr. 2011;2011(43):120-3. doi: 10.1093/jncimonographs/lgr034.

    PubMed 22043057

  • Gelman A, Stern HS, Carlin JB, Dunson DB, Vehtari A & Rubin DB. Bayesian data analysis. Chapman and Hall/CRC. 2013

  • Gianni L, Huang CS, Egle D, Bermejo B, Zamagni C & Thill M (2019, Dezember 12). Combining Atezolizumab with Neoadjuvant Chemotherapy Does Not Improve Pathologic Complete Response Rates for Patients with Triple-Negative Breast Cancer. SABCS 2019, Marc.

  • Gluz O, Liedtke C, Gottschalk N, Pusztai L, Nitz U, Harbeck N. Triple-negative breast cancer--current status and future directions. Ann Oncol. 2009 Dec;20(12):1913-27. doi: 10.1093/annonc/mdp492. Epub 2009 Nov 9.

    PubMed 19901010

  • Gluz O, Kolberg-Liedtke C, Prat A, Christgen M, Gebauer D, Kates R, Pare L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Pelz E, Nitz U, Kreipe HH, Harbeck N. Efficacy of deescalated chemotherapy according to PAM50 subtypes, immune and proliferation genes in triple-negative early breast cancer: Primary translational analysis of the WSG-ADAPT-TN trial. Int J Cancer. 2020 Jan 1;146(1):262-271. doi: 10.1002/ijc.32488. Epub 2019 Jun 19.

    PubMed 31162838

  • Gluz O, Nitz U, Liedtke C, Christgen M, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Bangemann N, Lindner C, Kuemmel S, Clemens M, Potenberg J, Staib P, Kohls A, von Schumann R, Kates R, Kates R, Schumacher J, Wuerstlein R, Kreipe HH, Harbeck N. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results. J Natl Cancer Inst. 2018 Jun 1;110(6):628-637. doi: 10.1093/jnci/djx258.

    PubMed 29228315

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection and Carboplatin in people with Triple-negative Breast Cancer, run by Palleos Healthcare GmbH at 1 site in Germany.

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 37 inclusion and 38 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 12 Jan 2026). 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?

Pathological Complete Response (ypT0/is, ypN0) (time frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.). 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 NCT04770272, which also lists 51 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 Jan 2026.

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