Trial · NCT04770272
Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy
NCT04770272, Phase 2, Terminated, Palleos Healthcare GmbH; results first posted 2026-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy. Trials, record NCT04770272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04770272
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy
- NCT number
- NCT04770272
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 442 participants, actual
- Lead sponsor
- Palleos Healthcare GmbH
- Conditions
- Triple-negative Breast Cancer
- Interventions
- Atezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection, Carboplatin, Paclitaxel, Epirubicin, Cyclophosphamide, Biopsy Arm A, Biopsy Arm B, Surgery
- First posted
- 2021-02-25
- Last updated
- 2026-01-12
- Results first posted
- 2026-01-12
- Limitations and caveats
Although the trial had to stop 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), 442 patients had already been screened and 363 had been randomized and were allowed to continue therapy.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Response (ypT0/is, ypN0) | 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). |
| Secondary | Number of Adverse Events by Grade | 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) |
| Secondary | Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%). | 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%. |
| Secondary | Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %). | 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%. |
| Secondary | Pathological Complete Response (ypT0, ypN0) | 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). |
| Secondary | Near Pathological Complete Response (Near pCR) | 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 |
| Secondary | Pathological Complete Response (no Invasive Tumor) | 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 |
| Secondary | Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment | 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. |
| Secondary | Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B. | 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. |
| Secondary | Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB) | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathological Complete Response (ypT0/is, ypN0) | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B. | The analysis was performed in the ITT population. The analysis population for the primary endpoint encompassed 339 patients with available pCR status (10 missing in each arm). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events by Grade | from date of randomization up to 24 months | Safety endpoints are based on a subset of the ITT population that actually received treatment. The safety population included 356 patients, 178 from Arm A and 178 from Arm B. Most frequent AEs (\>10% of patients) by system organ class are shown. | Adverse Events | NUMBER |
| SECONDARY | Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%). | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B | Patients with an ER/PR expression of \<1%. (Data for partients and an ER/PR expression of 1% to 10%, see below.) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %). | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B | Patients with an ER/PR expression of 1% to 10%. (Data for partients an ER/PR expression of \<1%, see above.) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pathological Complete Response (ypT0, ypN0) | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B. | Same as f0r Primary Endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Near Pathological Complete Response (Near pCR) | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pathological Complete Response (no Invasive Tumor) | after 29-30 weeks in Arm A and after 27-28 weeks in Arm B. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment | after 14/28 days (+/- 2 days) of treatment | Analyzed were available samples of participants (20 missing in arm A; 41 missing in arm B). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B. | after 28 days (+/- 2 days) of treatment | Analyzed were all available samples of participants (43 missing in arm A; 41 missing in arm B). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB) | after 14/28 days (+/- 2 days) of treatment | Analyzed were all available samples of participants (20 missing in arm A; 39 missing in arm B). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathological Complete Response (ypT0/is, ypN0) | Arm A | pCR = 0 (no pCR) | 58 | Participants | |
| Pathological Complete Response (ypT0/is, ypN0) | Arm B | pCR = 0 (no pCR) | 52 | Participants | |
| Pathological Complete Response (ypT0/is, ypN0) | Arm A | pCR = 1 (pCR achieved) | 112 | Participants | |
| Pathological Complete Response (ypT0/is, ypN0) | Arm B | pCR = 1 (pCR achieved) | 117 | Participants | |
| Number of Adverse Events by Grade | Arm A | CTCAE grade - all | 3281 | Adverse Events | |
| Number of Adverse Events by Grade | Arm B | CTCAE grade - all | 3313 | Adverse Events | |
| Number of Adverse Events by Grade | Arm A | CTCAE grade 1 | 1924 | Adverse Events | |
| Number of Adverse Events by Grade | Arm B | CTCAE grade 1 | 1937 | Adverse Events | |
| Number of Adverse Events by Grade | Arm A | CTCAE grade 2 | 847 | Adverse Events | |
| Number of Adverse Events by Grade | Arm B | CTCAE grade 2 | 849 | Adverse Events |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 180 | |
| Overall Study | STARTED | Arm B | 179 | |
| Overall Study | COMPLETED | Arm A | 134 | |
| Overall Study | COMPLETED | Arm B | 131 | |
| Overall Study | NOT COMPLETED | Arm A | 46 | |
| Overall Study | NOT COMPLETED | Arm B | 48 |
Source ClinicalTrials.gov
Adverse events286
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A | 93 | 178 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B | 108 | 178 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A | 51 | 178 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B | 49 | 178 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A | 106 | 178 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B | 98 | 178 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A | 66 | 178 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B | 66 | 178 | |
| other | Constipation | Gastrointestinal disorders | Arm A | 44 | 178 | |
| other | Constipation | Gastrointestinal disorders | Arm B | 52 | 178 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 1 | 180 |
| Total, all-cause mortality | Arm B | 0 | 179 |
| Total, other adverse events | Arm A | 178 | 178 |
| Total, other adverse events | Arm B | 178 | 178 |
| Total, serious adverse events | Arm A | 86 | 178 |
| Total, serious adverse events | Arm B | 87 | 178 |
Source ClinicalTrials.gov
Papers42
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A vs Arm B: Disease Free Survival (DFS) | Trial comparisons |
| Arm A vs Arm B: Event Free Survival (EFS) | Trial comparisons |
| Arm A vs Arm B: Overall Survival (OS). | Trial comparisons |
| Arm A vs Arm B: deaths from any cause | Trial comparisons |
| Arm A vs Arm B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04770272
GET https://conductscience.org/api/trials/v1/NCT04770272/results?page=2