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

December 18, 2025 updated by: Palleos Healthcare GmbH

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bottrop, Germany, 46236
        • Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe;

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
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.
Drug: Atezolizumab 840 MG in 14 ML Injection
840 mg Day 1 for two weeks
Other Names:
  • Tecentriq
Drug: Atezolizumab 1200 MG in 20 ML Injection
1200 mg Day 1 every 3 weeks for 8 cycles
Other Names:
  • Tecentriq
Drug: Carboplatin
Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Other Names:
  • Paraplatin
Drug: Paclitaxel
Paclitaxel 80 mg/m² IV weekly x 12 cycles
Other Names:
  • Abraxane
  • Onxol
Drug: Epirubicin
90 mg/m2, day 1 for 4 cycles (12 weeks)
Other Names:
  • Paxene
Drug: Cyclophosphamide
600 mg/m2, day 1 for 4 cycles (12 weeks)
Other Names:
  • Cytoxan
Procedure: Biopsy Arm A
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.
Procedure: Surgery
After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
Active Comparator: Arm B
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.
Drug: Atezolizumab 1200 MG in 20 ML Injection
1200 mg Day 1 every 3 weeks for 8 cycles
Other Names:
  • Tecentriq
Drug: Carboplatin
Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Other Names:
  • Paraplatin
Drug: Paclitaxel
Paclitaxel 80 mg/m² IV weekly x 12 cycles
Other Names:
  • Abraxane
  • Onxol
Drug: Epirubicin
90 mg/m2, day 1 for 4 cycles (12 weeks)
Other Names:
  • Paxene
Drug: Cyclophosphamide
600 mg/m2, day 1 for 4 cycles (12 weeks)
Other Names:
  • Cytoxan
Procedure: Surgery
After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
Procedure: Biopsy Arm B
1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (ypT0/is, ypN0)
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Pathological Complete Response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0).
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near Pathological Complete Response (Near pCR)
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Near pCR defined as residual tumor <5 mm in the breast irrespective of in situ and lymph nodes status
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Number of Adverse Events by Grade
Time Frame: from date of randomization up to 24 months
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)
from date of randomization up to 24 months
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%).
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B
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%.
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %).
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B
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%.
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B
Pathological Complete Response (ypT0, ypN0)
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Pathological complete response defined as no tumor cells (invasive and no non-invasive) in the breast but also in the lymph nodes (ypN0, ypT0).
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Pathological Complete Response (no Invasive Tumor)
Time Frame: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Pathological Complete Response defined as no invasive tumor in the breast, irrespective of lymph node status
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
Time Frame: after 14/28 days (+/- 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.
after 14/28 days (+/- 2 days) of treatment
Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B.
Time Frame: after 28 days (+/- 2 days) of treatment
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.
after 28 days (+/- 2 days) of treatment
Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB)
Time Frame: after 14/28 days (+/- 2 days) of treatment
TILs after 14/28 days (+/- 2 days) of treatment as continuous predictor. See general comments to biomarker endpoints above.
after 14/28 days (+/- 2 days) of treatment
Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 28 Days
Time Frame: after 28 days (+/- 2 days) of treatment

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

See general comments to biomarker endpoints above.
after 28 days (+/- 2 days) of treatment
Complete Cell Cycle Arrest (CCCA) After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
Time Frame: after 14/28 days (+/- 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.
after 14/28 days (+/- 2 days) of treatment
Complete Cell Cycle Arrest (CCCA) After 28 Days (+/- 2 Days) of Treatment
Time Frame: 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.
after 28 days (+/- 2 days) of treatment
Low Cellularity (< 500 Tumor Cells) After 14 (Arm A)/28 Days (Arm B) (+/- 2 Days) of Treatment
Time Frame: after 14/28 days (+/- 2 days) of treatment
Low cellularity: < 500 tumor cells after 14/28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.
after 14/28 days (+/- 2 days) of treatment
Low Cellularity (< 500 Tumor Cells) After 28 Days (+/- 2 Days) of Treatment
Time Frame: 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.
after 28 days (+/- 2 days) of treatment
Combined Early Response After 14 (Arm A)/28 (Arm B) Days (+/- 2 Days) of Treatment
Time Frame: 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% See general comments to biomarker endpoints above.
after 14/28 days (+/- 2 days) of treatment
Combined Early Response After 28 Days (+/- 2 Days) of Treatment
Time Frame: 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.
after 28 days (+/- 2 days) of treatment
Disease Free Survival (DFS)
Time Frame: 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
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.
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
Overall Survival (OS).
Time Frame: from randomization up to 24 months until date of death from any cause.
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.
from randomization up to 24 months until date of death from any cause.
Event Free Survival (EFS)
Time Frame: 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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palleos Healthcare GmbH

Collaborators

Roche Pharma AG
University Hospital, Essen
University Hospital Erlangen
Phaon Scientific GmbH

Investigators

  • Study Director: Iris Reiser, Dr., Palleos Healthcare GmbH
  • Principal Investigator: Hans-Christian Kolberg, Prof. Dr., Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe; 46236 Bottrop

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 6, 2023

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phaon1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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