Trial · NCT04770272
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 28 Days | 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. |
| Secondary | Complete Cell Cycle Arrest (CCCA) After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment | 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. |
| Secondary | Complete Cell Cycle Arrest (CCCA) After 28 Days (+/- 2 Days) of Treatment | 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. |
| Secondary | Low Cellularity (< 500 Tumor Cells) After 14 (Arm A)/28 Days (Arm B) (+/- 2 Days) of Treatment | 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. |
| Secondary | Low Cellularity (< 500 Tumor Cells) After 28 Days (+/- 2 Days) of Treatment | 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. |
| Secondary | Combined Early Response After 14 (Arm A)/28 (Arm B) Days (+/- 2 Days) of Treatment | 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. |
| Secondary | Combined Early Response After 28 Days (+/- 2 Days) of Treatment | 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. |
| Secondary | Disease Free Survival (DFS) | 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. |
| Secondary | Overall Survival (OS). | 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. |
| Secondary | Event Free Survival (EFS) | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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