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- Perjeta (pertuzumab) / Roche
Analysis of pathological complete response (PCR) and impact of modifiable risk factors on the premature discontinuation of pertuzumab use in early stage HER-2 breast cancer: A retrospective single-institutional study. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4232;
This is due to adverse effects, diarrhea being the most notable. However, the PCR rate difference was not statistically significant (55.56 vs 51.85, P value 0.77) in patients who completed treatment versus those who did not.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
Decreased HER2 expression in residual disease following neoadjuvant therapy in patients with HER2-positive breast cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4226;
In our retrospective cohort, decreased HER2 expression by IHC following neoadjuvant treatment was associated with lower recurrence rates. If confirmed, RD HER2 IHC expression could be used as a prognostic biomarker to select patients for more or less aggressive adjuvant therapy, stratify patients in adjuvant trials, and identify patients who may benefit from more intensive post therapy surveillance.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Combined role of the neutrophil/lymphocyte ratio and Neo-Bioscore in neoadjuvant therapy in HER2-positive early breast cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4220;
High NLR, despite being a poor prognostic factor, seems to be a predictor factor of pCR in Pts treated with Pz-Tz. The increase in NLR and clinical NbS are factors to take into account to predict the efficacy of NeoT in eHBC Pts.
- Herceptin (trastuzumab) / Roche, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche, Perjeta (pertuzumab) / Roche
Efficacy and safety of neoadjuvant double anti-Her2 blockade combined with anthracycline-free chemotherapy in locally advanced breast cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4219;
The main advantage is the intensification of double lock dose, without anti Her2 window period, avoiding the addition of anthracyclines and, therefore, cardiac toxicity. pRC and toxicity profile results were better than other regimen proposed in other studies.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
INSIGHT-HER2BC: Real-world evidence of TCHP regimen to describe the best patient profile and open up questions () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4214;
pRC and toxicity profile results were better than other regimen proposed in other studies. We ambispectively reviewed medical records of pts with eHER2+ BC who underwent NAT 6xTCHP (6 docetaxel/carboplatin + trastuzumab/pertuzumab) at three Moscow oncology centers since Jan
- Cipterbin (inetetamab) / 3SBio, Perjeta (pertuzumab) / Roche
Neoadjuvant inetetamab combined with pertuzumab, paclitaxel, and carboplatin (TCbIP) for locally advanced HER2-positive breast cancer: Primary analysis of a phase II study. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4206;
P2
TCbIP displays a promising efficacy (pCR rate of 66.7%) and manageable toxicity in patients with HER2-positive LA breast cancer in the neoadjuvant setting. Clinical trial information: NCT05749016.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Phase II neoadjuvant trial of albumin-bound paclitaxel, trastuzumab and pertuzumab followed by anthracycline based regimens in patients with operable HER2 positive breast cancer (OMC-BC05). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4203;
Patients are treated with neoadjuvant nab-paclitaxel(260 mg/m2 ), Trastuzumab and Pertuzumab followed by EC(Epirubicin 90 mg/m2 ,Cyclophosphamide 600 mg/m2) or AC(Doxorubicin 60 mg/m2 ,Cyclophosphamide 600 mg/m2) or FEC(Fluorouracil 500mg/m2, Epirubicin 100 mg/m2 ,Cyclophosphamide 500 mg/m2 ) q21d x 4. Neoadjuvant treatment using albumin-bound Paclitaxel, Trastuzumab and Pertuzumab followed by Anthracycline based regimens appears to be effective especially in pure HER2 type or IHC 3+ cases.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Role of plasma circulating HER2/EFTUD2 ratio in predicting pathological complete response (pCR) after neoadjuvant dual anti-HER2 therapy in HER2-positive breast cancer (HER2+ BC). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4201;
A high pre-treatment plasma circulating HER2/EFTUD2 ratio is associated with large tumor size and high tumor grade in HER2+ BC. The decline of HER2/EFTUD2 ratio after neoadjuvant dual anti-HER2 therapy predicts pCR, and may serve as a potential biomarker for treatment de-escalation.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Real-world, single-center experience on the outcomes of neoadjuvant chemotherapy and trastuzumab alone or in combination with pertuzumab in human epidermal growth factor receptor-2 breast cancer patients. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4199;
Neoadjuvant chemotherapy with dual HER2-blockade had higher pCR and survival rates compared with the single HER2-blockade strategy in HER2 positive breast cancer. >ER, estrogen receptor; PR, progesterone receptor; pCR, pathological response rate.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Defendor special: Interim analysis of TCHP with primary empegfilgrastim prophylaxis (long-acting G-CSF) for treatment outcomes in early HER2+ breast cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4197;
P=N/A
TCHP+E shows superior pCR rate vs TCHP+F in the ITT and HER2 (3+) population. The obtained results affirm data of preclinical research on the ability of G-CSF to switch tumor immunity from
- Perjeta (pertuzumab) / Roche
Incidence of hypomagnesemia in patients with HER2+ breast cancer treated with pertuzumab. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4182;
Our results do not indicate clinical monitoring of hypomagnesemia is necessary for patients receiving P. >* The values were converted into categorical variables (Y/N), since both institutions had different lab reference values.**4th trial date unavailable for 2 patients. One patient received only 3 cycles of P; one patient transferred care elsewhere after 3 cycles of P.
- Ogivri (trastuzumab-dkst) / Biocon, Herceptin (trastuzumab) / Roche
A prospective real-world study to assess the effectiveness and safety of trastuzumab biosimilar in the adjuvant treatment of HER2-positive breast cancer: Preliminary safety results. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4147;
P=N/A
Clinical trial information: NCT03892655. >
- Evolution of breast cancer management in the Dominican Republic in the 21st century. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4119;
It highlights the efforts made to apply guidelines on breast cancer management in general and global objective response to neoadjuvant regimen. It also highlights the need to implement more primary prevention and early detection since 52% of patients belong to the locally advanced category.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Cardiac dysfunction (CD) among breast cancer survivors (BCS): Role of cardiotoxic therapy and cardiovascular risk factors. (Available On Demand; Poster Bd # 446) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3673;
In this large cohort of BCS followed longitudinally for an extended period, exposure to potentially cardiotoxic therapy results in a substantial burden of CD; the risk increases over time, and with CVRFs. These results provide evidence for close surveillance of BC survivors at increased risk of CD for extended periods, and aggressive management of CVRFs before, during and after BC.
- Perjeta (pertuzumab) / Roche
Pertuzumab retreatment in patients with HER2-positive locally advanced/metastatic breast cancer: Overall survival results of a phase III randomized trial (JBCRG-M05: PRECIOUS). (Live Stream | Hall D2; Poster Bd # 236) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3328;
P3
These results provide evidence for close surveillance of BC survivors at increased risk of CD for extended periods, and aggressive management of CVRFs before, during and after BC. Background: We previously reported that pertuzumab (P) retreatment in combination with trastuzumab (T) + chemotherapy based on physician
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Tukysa (tucatinib) / Seagen
Efficacy of tucatinib+trastuzumab+capecitabine (TTC) after trastuzumab-deruxtecan (T-DXd) exposure in Her2-positive metastatic breast cancer: A French multicentre retrospective study. (Live Stream | Hall D2; Poster Bd # 235) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3327;
In this large retrospective cohort, TTC shows significant efficacy for patients with HER2+ MBC previously exposed to T-DXd. Data and subgroup analyses will be updated for the meeting.
- UCLA B-13: A phase 1b trial evaluating the safety of ribociclib, tucatinib, and trastuzumab in patients with metastatic, HER2+ breast cancer and a multicenter, randomized, open-label, phase 2 study of preoperative treatment with ribociclib, trastuzumab, tucatinib, with or without fulvestrant versus docetaxel, carboplatin, trastuzumab, and pertuzumab in HR+/HR-, HER2+ breast cancer. (On Demand | Hall A; Poster Bd # 334b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3308;
P1b
Other endpoints include safety, changes in Ki67 expression, RCBi, biomarker analysis, and health-related quality of life. Clinical trial information: NCT05319873.
- Tukysa (tucatinib) / Seagen, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer. (On Demand | Hall A; Poster Bd # 334a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3307;
P3
Enrollment is ongoing in the US, Canada, Brazil, APAC and EU countries with additional sites planned. Clinical trial information: NCT05132582.
- ORM-5029 / Orum Therap
A phase 1, first-in-human, open label, escalation and expansion study of ORM-5029, a highly potent GSPT1 degrader targeting HER2, in patients with HER2-expressing advanced solid tumors. (On Demand | Hall A; Poster Bd # 333b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3306;
P1
ORM-5029 is a first-in-class human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) comprised of SMol006, a highly potent GSPT1 degrader, conjugated to pertuzumab, a clinically validated antibody...ORM-5029 showed robust in vitro and in vivo efficacy in multiple HER2-expressing models with comparable activity to trastuzumab deruxtecan and strong activity in trastuzumab emtansine-refractory models...Escalation cohort 1 was completed without DLT; enrollment in cohort 2 began as of December 2022. Clinical trial information: NCT05511844.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
Real-world treatment patterns in patients with HER2+ unresectable or metastatic breast cancer: Interim results from HER2 REAL Asia cohort. (On Demand | Hall A; Poster Bd # 268) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3239;
P=N/A
Clinical trial information: NCT04857619. >aReported in ?4.0% pts.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Cardiac function of long-responders to dual anti-HER2 antibodies amongst patients with HER2 positive advanced breast cancer. (On Demand | Hall A; Poster Bd # 264) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3235;
It is safe to de-escalate the cardiac surveillance for this population. >
- Cipterbin (inetetamab) / 3SBio, AiRuiKa (camrelizumab) / Jiangsu Hengrui Pharma, utidelone (UTD1) / Beijing Biostar Technologies
Anti-HER2 antibody inetetamab plus camrelizumab and utidelone for pretreated HER2-positive metastatic breast cancer: Final results from the phase 2 ICU trial. (On Demand | Hall A; Poster Bd # 263) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3234;
P2
The ICU study showed a favorable benefit-risk profile and is an important option for Chinese patients with HER2-positive MBC after at least two lines of HER2-directed therapies with trastuzumab and TKIs. Clinical trial information: NCT04681287.
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Preclinical and early clinical data of ZN-1041 in combination with trastuzumab deruxtecan to treat breast cancer with or without CNS metastases. (On Demand | Hall A; Poster Bd # 262) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3233;
P1
Encouraging efficacy was observed in treatment-refractory settings. Additional safety and efficacy data of ZN-1041 in combination with TDM1, TDXd or HP are warranted.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
The evolving landscape of chemotherapy for the treatment of early-stage breast cancer from 2006-2019: Results of a retrospective cohort study. (On Demand | Hall A; Poster Bd # 92) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2699;
While the prevalence of women receiving chemotherapy in our cohort has decreased since 2006, there has been a marked increase in neoadjuvant chemotherapy among those women receiving chemotherapy, as well as an increase in both the duration of chemotherapy treatment and number of associated chemotherapy administration visits, a pattern specifically observed in non-trastuzumab/pertuzumab containing regimens.The change in average duration and number of visits represents a shift in treatment patterns for patients and providers. Understanding trends in breast cancer chemotherapy is useful to inform clinical care and administrative planning for sites delivering chemotherapy for early-stage breast cancer.
- Perjeta (pertuzumab) / Roche
Racial disparities in utilization of first line targeted therapies for metastatic breast cancer. (On Demand | Hall A; Poster Bd # 20) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2629;
Racial disparities were significant for oral CDK4/6 inhibitors but not for intravenous pertuzumab. >
- trastuzumab mafodotin (IKS014) / Iksuda Therap
FS-1502 in HER2-positive advanced breast cancer: Results from an open-label, phase 1 study. (On Demand | Hall A; Poster Bd # 242) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1746;
P1
> All pts had previously received anti-HER2 therapy, among which trastuzumab
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Integration of trastuzumab (T), with or without pertuzumab (P), into perioperative chemotherapy (CT) of HER-2 positive gastric (GC) and esophagogastric junction cancer (EGJC): First results of the EORTC 1203 INNOVATION study, in collaboration with the Korean Cancer Study Group, and the Dutch Upper GI Cancer group. (Available On Demand; Poster Bd # 378) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1186;
P2
However, CT+T showed interesting response rates, especially with FLOT as CT backbone. Follow-up data including survival is necessary to define the clinical value of this regimen.
- A systematic review and meta-analysis of intrathecal versus alternate routes of delivery for HER2-targeted therapies in patients with HER2+ breast cancer leptomeningeal metastases. (Available On Demand; Poster Bd # 391) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1067;
We also present the first evidence supporting the efficacy of TDXd compared to alternative strategies for this patient population. Although the number of patients receiving TDXd in this cohort is small, this novel agent offers promise for this patient population and requires further investigation in prospective studies.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Gene expression signatures, stromal tumor infiltrating lymphocytes (sTILs), and change in tumor cellularity to predict pathological complete response (pCR) after 12 week de-escalated neoadjuvant endocrine therapy (ET) vs paclitaxel + dual HER2 blockade in the (Available On Demand; Poster Bd # 349) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1029;
P2
Future neoadjuvant trials are needed to prospectively test the use of baseline gene expression and sTILs analysis, and early on-treatment cellularity measurement to select patients with HR+/HER2+ tumors for de-escalated endocrine-therapy-based approaches. Clinical trial information: NCT03272477.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
A phase II study of concurrent WOKVAC vaccination with neoadjuvant chemotherapy and HER2-targeted monoclonal antibody therapy. (Available On Demand; Poster Bd # 455b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1023;
P2
Targeted Accrual: The study will accrue up to 16 patients. Clinical trial information: NCT04329065.
- Keytruda (pembrolizumab) / Merck (MSD)
Neoadjuvant HER2-targeted therapy +/- immunotherapy with pembrolizumab (neoHIP): An open label randomized phase II trial. (Available On Demand; Poster Bd # 454b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1021;
P2
Clinically, pembrolizumab (K)-mediated ICI plus HER2-directed therapy with trastuzumab (H) was safe and demonstrated modest activity in H-resistant HER2-positive (HER2+) metastatic breast cancer...Moreover, the synergy of H and K with paclitaxel (T) may overcome the need for dual HER2-blockade with H plus pertuzumab (P)...Exploratory correlative studies will characterize potential immune biomarkers predictive of efficacy and/or toxicity. Clinical trial information: NCT03747120.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Whole-genome sequencing based assessment of HER2 focal amplification for precision oncology of breast cancers. (Available On Demand; Poster Bd # 439) - Apr 26, 2023 - Abstract #ASCO2023ASCO_997;
Among 28 patients who received six cycles of docetaxel/carboplatin/trastuzumab/pertuzumab neoadjuvant therapy followed by curative surgery, 21 patients had HER2 focal amplification and 14 (66.7%) achieved pathologic complete remission (pCR). Our analysis demonstrates that WGS enables better classification of the HER2 amplification status in breast cancer than IHC with ISH, suggesting WGS as a sensitive tool for screening breast cancers for anti-HER2-targeted therapies.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Neoadjuvant therapy of HER2 directed conventional dendritic cell (DC1) intratumoral (IT) therapy plus weekly paclitaxel, trastuzumab, and pertuzumab in patients with HER-2 positive breast cancer: NATASHA trial. (Available On Demand; Poster Bd # 426) - Apr 26, 2023 - Abstract #ASCO2023ASCO_984;
P2
The 100 million DC1 led to a significant decrease in peripherally circulating anti-HER2 T cell response at week 6 following IP and improved radiologic tumor responses which correlates with a higher likelihood of pCR. Data from another IT DC1 trial suggests decreased circulating HER2 responsive T cells are due to increased trafficking of reactive T cells out of circulation into the tumor possibly leading to an enhanced anti-tumor effect.
- Perjeta (pertuzumab) / Roche
Invasive disease free survival and brain metastasis rates in patients treated with neoadjuvant chemotherapy with trastuzumab and pertuzumab. (Available On Demand; Poster Bd # 419) - Apr 26, 2023 - Abstract #ASCO2023ASCO_977;
In those with RD, 36% lost HER2+ status; IDFS events appeared similar in those with HER2+ RD versus those with HER2- RD. The HER2 loss rate is higher than reported in KATHERINE possibly due to majority of pts receiving dual HP as NAST.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
Decision value of the circulating tumor DNA on the adjuvant anti-Her2 regimens in patients with Her2-positive breast cancer treated with neoadjuvant therapy. (Available On Demand; Poster Bd # 388) - Apr 26, 2023 - Abstract #ASCO2023ASCO_946;
Of the 117 patients enrolled, there were 18 patients receiving adjuvant T-DM1 and 99 receiving trastuzumab (N = 70) or trastuzumab plus pertuzumab (N = 29). The presence of ctDNA in patients with early-stage Her2-positive breast cancer after NAT was independently associated with disease recurrence; however, ctDNA(+) after NAT became inconsiderable when patients were treated with adjuvant T-DM1 therapy, which represented ctDNA(+) as an important factor determining adjuvant anti-Her2 regimen.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
The worldwide impact of HER2-targeted treatments in women with breast cancer: An epidemiological modeling study. (Available On Demand; Poster Bd # 373) - Apr 26, 2023 - Abstract #ASCO2023ASCO_931;
Further research may elucidate treatment-related reductions in costs to society as a result of population-level improvements in disease outcomes for breast cancer survivors. Given the expected rise in the burden of breast cancer globally, therapeutic advances and increased treatment utilization may further accelerate global patient benefit.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
3-year invasive disease-free survival (iDFS) of the strategy-based, randomized phase II PHERGain trial evaluating chemotherapy (CT) de-escalation in human epidermal growth factor receptor 2-positive (HER2[+]) early breast cancer (EBC). (Available On Demand) - Apr 26, 2023 - Abstract #ASCO2023ASCO_910;
These results appear comparable to those reported in several studies for the combination of neoadjuvant CT and dual HER2 blockade. This strategy identifies about a third of HER2[+] EBC pts who may safely omit CT with significantly reduced toxicity.
- || Kadcyla (ado-trastuzumab emtansine) / Roche, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre, Perjeta (pertuzumab) / Roche
Review, Journal: Individualizing Curative-Intent Therapy in HER2-Positive Early-Stage Breast Cancer. (Pubmed Central) - Apr 25, 2023
Trastuzumab emtansine (T-DM1) has been shown to improve outcomes if pathological complete response (pCR) is not achieved, and adjuvant extended therapy with neratinib has increased disease-free survival (DFS) and may have an impact in central nervous system (CNS) recurrences...Immune infiltration, intrinsic subtype, intratumoral heterogeneity, and dynamic changes during treatment have been described as important prognostic and/or predictive features. The integration of all these factors will be key in the proper identification of the true risk, and individualized treatment strategy, for each patient.
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma, Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date: Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer (clinicaltrials.gov) - Apr 25, 2023
P2, N=18, Recruiting, Sponsor: Mayo Clinic
The integration of all these factors will be key in the proper identification of the true risk, and individualized treatment strategy, for each patient. Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||| Ibrance (palbociclib) / Pfizer
Trial completion date, Trial primary completion date, Metastases: PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) - Apr 25, 2023
P3, N=496, Active, not recruiting, Sponsor: Alliance Foundation Trials, LLC.
Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2023 Trial completion date: Mar 2026 --> Jul 2026 | Trial primary completion date: May 2023 --> Dec 2023
- | Herceptin (trastuzumab) / Roche
Enrollment open, Metastases: STOP-HER2: Stopping Trastuzumab in HER2+ MBC (clinicaltrials.gov) - Apr 25, 2023
P2, N=82, Recruiting, Sponsor: Dana-Farber Cancer Institute
Trial completion date: Mar 2026 --> Jul 2026 | Trial primary completion date: May 2023 --> Dec 2023 Not yet recruiting --> Recruiting
- | Perjeta (pertuzumab) / Roche
Enrollment closed: HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (clinicaltrials.gov) - Apr 25, 2023
P1, N=31, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | paclitaxel / Generic mfg., docetaxel / Generic mfg.
Trial completion date, Trial primary completion date: Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer (clinicaltrials.gov) - Apr 24, 2023
P2, N=249, Active, not recruiting, Sponsor: ECOG-ACRIN Cancer Research Group
Recruiting --> Active, not recruiting Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023
- ||| HER-2 pulsed DC1 / ImmunoRestoration
Enrollment change: NATASHA: Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab (clinicaltrials.gov) - Apr 24, 2023
P2, N=53, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023 N=34 --> 53
- ||| pertuzumab biosimilar / Mabscale
New P1 trial: Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta (clinicaltrials.gov) - Apr 24, 2023
P1, N=114, Not yet recruiting, Sponsor: Mabscale, LLC
- || Tagrisso (osimertinib) / AstraZeneca, Perjeta (pertuzumab) / Roche
True. And mostly happens when u want to give a high end drug like a Pertuzumab or Osimertinib. (Twitter) - Apr 22, 2023
- ||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Trial initiation date: ADAPTHER2-IV: NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (clinicaltrials.gov) - Apr 21, 2023
P2, N=402, Not yet recruiting, Sponsor: West German Study Group
N=34 --> 53 Initiation date: Mar 2023 --> Aug 2023
- ||| Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial (clinicaltrials.gov) - Apr 20, 2023
P3, N=154, Active, not recruiting, Sponsor: Hoffmann-La Roche
Initiation date: Mar 2023 --> Aug 2023 Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> Dec 2025
- ||| Herceptin (trastuzumab) / Roche, Actimmune (interferon gamma-1 b) / Clinigen, Amgen, Perjeta (pertuzumab) / Roche
Trial completion, Trial completion date: MCC-18936: Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer (clinicaltrials.gov) - Apr 19, 2023
P1/2, N=51, Completed, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> Dec 2025 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2023
- || Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date: Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (clinicaltrials.gov) - Apr 18, 2023
P4, N=108, Recruiting, Sponsor: Institut fuer Frauengesundheit
Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2023 Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jan 2022 --> Apr 2023