Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07178730 | NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer | PHASE3 | NOT YET_RECRUITING | 765 | — | — | Jun 30, 2026 | Mar 31, 2033 | May 6, 2026 | - | — |
| NCT02574455 | Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) | PHASE3 | COMPLETED | 529 | — | — | Nov 7, 2017 | Dec 8, 2020 | Jun 15, 2022 | 230 | United States, Belgium +5 |
| NCT06665178 | Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic Breast Cancer | PHASE2 | RECRUITING | 20 | — | — | Mar 31, 2025 | Dec 1, 2028 | Jun 25, 2025 | 1 | Canada |
| NCT06263543 | Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC | PHASE2 | RECRUITING | 75 | — | — | Jun 17, 2024 | Dec 1, 2026 | Dec 26, 2025 | 3 | United States |
| NCT05675579 | A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC) | PHASE2 | ACTIVE NOT_RECRUITING | 27 | — | — | May 23, 2023 | Dec 31, 2026 | May 20, 2026 | 1 | United States |
| NCT04468061 | Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC | PHASE2 | RECRUITING | 110 | — | — | Jul 20, 2020 | Apr 1, 2029 | Apr 29, 2026 | 15 | United States |
EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy (same definition as iDFS) according to STEEP 2.0 criteria \[103\]
EFS after 36 months defined as time from registration to any invasive breast cancer event, death, or secondary malignancy or local progress precluding surgery in neoadjuvant treated patients
pCR defined as no invasive disease in breast and lymph nodes (ypT0/is, ypN0) in patients of both arms
PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to \[≥\] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Number and identification of altered/mutated genes in the tumors in the subgroup of patients with a longer PFS on SG post T-DXd compared to the tumors in the subgroup of patients with a shorter PFS on SG post T-DXd.
ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator.
Compare PFS of patients randomized to receive sacituzumab govitecan in combination with pembrolizumab (Arm A) versus those randomized to receive sacituzumab govitecan monotherapy (Arm B). Defined as the time from study randomization to disease progression, per RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Cohort I (non-randomized) | OTHER | Cohort I will include patients with clinical stage II disease at baseline who have a cCR after up to 12 weeks of NACT with CARBO/PAC and PEM. After surgery, patients with a pCR (ypT0/is, ypN0) will not receive further chemotherapy (CTx) but continue on SoC treatment according to current valid treatment guidelines for breast cancer at investigator´s discretion. Patients with residual disease should be considered for postoperative SoC treatment, which may include further CTx (e.g., AC/EC x 4, q2w or q3w or Capecitabine) plus PEM or Olaparib (in patients with gBRCA mutations) according to current valid treatment guidelines for breast cancer and per investigator´s discretion. |
| Cohort II (randomized) - Sacituzumab govitecan + pembrolizumab (SG+PEM) | EXPERIMENTAL | neoadjuvant SG+PEM (4 cycles), followed by surgery and pCR-dependent post-neoadjuvant SoC treatment according to current valid treatment guidelines for breast cancer and per investigator´s discretion. |
| Cohort II (randomized) - Standard-of-care chemotherapy + pembrolizumab (SoC CTx+PEM) | ACTIVE_COMPARATOR | SoC, e.g., AC x 4 + PEM or EC x 4 + PEM, followed by surgery and pCR-dependent post-neoadjuvant SoC treatment, e.g., AC x 4 \* PEM or EC x 4 + PEM, or Capecitabine + PEM or Olaparib (in patients with gBRCA mutations), according to current valid treatment guidelines for breast cancer and per investigator´s discretion. |
| Sacituzumab Govitecan | EXPERIMENTAL | Participants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs). |
| Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | Participants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. |
| Sacituzumab Govitecan (SG) Infusion | EXPERIMENTAL | SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity. |
| Sacituzumab Govitecan and Pembrolizumab | EXPERIMENTAL | Participants will receive drug on Days 1 and 8 of Cycles 1-4, Participants will receive sacituzumab govitecan by vein. Participants will receive drug on Days 1, 8, and 15 of each cycle, Participants will receive pembrolizumab by vein. |
| Sacituzumab Govitecan + Pembrolizumab | EXPERIMENTAL | Participants will receive Sacituzumab Govitecan + Pembrolizumab at a pre-determined dose during a 21 day cycle. Sacituzumab Govitecan will be given on days 1 and 8 of the 21 day cycle Pembrolizumab will be given on day 1 of the 21 day cycle. |
| Retreatment | EXPERIMENTAL | Participants randomized to the combination arm (Sacituzumab Govitecan + Pembrolizumab) who stop with CR after at least 24 weeks of treatment may be eligible for additional pembrolizumab and/or sacituzumab govitecan therapy if they progress after stopping study treatment. This is termed the Second Course Phase and is only available if the study remains open and the subject meets conditions. . |
| Name | Type | Description |
|---|---|---|
| Sacituzumab govitecan | DRUG | SG is administered at 10 mg/kg as an intravenous (i.v.) infusion on Days 1 and 8 of a 21-day cycle. The dose of SG will be calculated based on actual weight at randomization (using weight obtained either at enrolment or on Cycle 1 Day 1) and remains constant throughout the study, unless there is a \> 10% change in body weight from baseline. Modifications to the study drug doses administered should be made for a \> 10% change in body weight from baseline and according to local and regional prescribing standards. Dose modifications for changes in body weight \< 10% may be made according to local institutional guidelines. SG is administered via i.v. infusion as described below with additional information available in the current version of the SmPC. |
| Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA] | DRUG | Pembrolizumab 200 mg will be administered as a 30-minute i.v. infusion every 3 weeks. |
| SoC Chemotherapy | DRUG | Standard of care chemotherapy as per common treatment guidelines and recommendations |
| Eribulin | DRUG | Administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). |
| Capecitabine | DRUG | 1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. |
| Gemcitabine | DRUG | 800 to 1200 mg/m\^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. |
| Vinorelbine | DRUG | 25 mg/m\^2 will be administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy. |
| Pembrolizumab | DRUG | Given by IV (vein) |
Inclusion Criteria: Minimal eligibility criteria to be met for registration in the clinical trial: 1. TNBC: ER = 0%, PR = 0%, and HER2- (i.e., immunohistochemistry \[IHC\] with DAKO score ≤ 1 or fluorescence in situ hybridization \[FISH\]-negative) 2. or TNBC-like: ER ≤ 10% positive cells in IHC, ...