- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Tukysa (tucatinib) / Pfizer, paclitaxel trevatide (ANG1005) / Angiochem
Review, Journal: Pharmacotherapy for leptomeningeal disease in breast cancer. (Pubmed Central) - Jan 2, 2024
Large retrospective cohorts with various inclusion criteria and treatment regimens provide some real-world data. However, there remains an urgent need for randomised clinical trials which include patients with LMD across all breast cancer subtypes.
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Apr 20, 2023
P3, N=150, Not yet recruiting,
However, there remains an urgent need for randomised clinical trials which include patients with LMD across all breast cancer subtypes. Trial primary completion date: Mar 2024 --> Dec 2024
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Apr 22, 2022
P3, N=150, Not yet recruiting,
Trial primary completion date: Mar 2024 --> Dec 2024 Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- |||||||||| NanoPac (paclitaxel nanoformulation) / NanOlogy
Review, Journal, IO biomarker: Nanotechnology, in silico and endocrine-based strategy for delivering paclitaxel and miRNA: Prospects for the therapeutic management of breast cancer. (Pubmed Central) - Mar 4, 2022
miRNA delivery to a specific target site, the development of paclitaxel and miRNA formulations, and nanotechnological strategies for the delivery of nanopaclitaxel in the management of breast cancer are discussed...An in silico analysis revealed that ANG1005 and Abraxane nanoformulations have superior and significantly enhanced interactions with the proteins α-tubulin and Bcl-2...miRNAs can revert abnormal gene expression to normalcy; since miRNAs serve as tumor suppressors. Therefore, restoration of particular miRNAs levels as a replacement therapy may be an effective endocrine potential strategy for treating ER positive/ negative breast cancers.
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Feb 15, 2022
P3, N=150, Not yet recruiting,
Therefore, restoration of particular miRNAs levels as a replacement therapy may be an effective endocrine potential strategy for treating ER positive/ negative breast cancers. Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Sep 9, 2021
P3, N=150, Not yet recruiting,
Even though the study pre-set rule for iORR per IRF was not met in this heavily pretreated population, a notable CNS and systemic treatment effect was seen in all patients, particularly in LC patients, including symptom improvement and prolonged overall survival compared to historical control. Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Jun 8, 2021
P3, N=150, Not yet recruiting,
Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Jun 2023 Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Mar 2023
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Feb 17, 2021
P3, N=150, Not yet recruiting,
Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Mar 2023 Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - May 26, 2020
P3, N=150, Not yet recruiting,
Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Aug 2022 --> Dec 2022 Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Jun 2022
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Apr 2, 2020
P3, N=150, Not yet recruiting,
Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Jun 2022 Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Mar 2022
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Nov 20, 2019
P3, N=150, Not yet recruiting,
Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Mar 2022 Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Jun 2021 --> Oct 2021
- |||||||||| irinotecan / Generic mfg.
Systemic therapy for breast cancer brain metastases (Stars at Night Ballroom 3&4 - 3rd Level) - Oct 19, 2019 - Abstract #SABCS2019SABCS_2012;
P2
Finally, there is evidence that monoclonal antibodies and antibody drug conjugates may have CNS activity; for example, trastuzumab-emtansine has been reported to lead to CNS regressions in up to 40% of patients, based upon case series from several institutions, and in preliminary data from the PATRICIA study, the regimen of high dose trastuzumab (6 mg/kg weekly) plus pertuzumab was associated with CNS responses and prolonged stable disease in a subset of patients...Results of the JPBO study demonstrate modest CNS efficacy of abemaciclib in patients with ER+ breast cancer, but the CNS ORR was <10%...An ongoing randomized trial testing carboplatin +/- veliparib is asking the question of whether a PARP inhibitor may add to platinum efficacy both intracranially and extracranially...Diverse agents including anthracyclines, capecitabine, platinum salts, and irinotecan have been reported to be associated with CNS response in breast cancer patients. Newer compounds (NKTR-102, Nal-IRI, tesetaxel, ANG1005) which have been engineered to improve upon CNS penetration and/or CNS residence time are in clinical development and testing.
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial initiation date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Jul 8, 2019
P3, N=150, Not yet recruiting,
Newer compounds (NKTR-102, Nal-IRI, tesetaxel, ANG1005) which have been engineered to improve upon CNS penetration and/or CNS residence time are in clinical development and testing. Trial completion date: Dec 2021 --> Mar 2022 | Initiation date: Sep 2019 --> Dec 2019 | Trial primary completion date: Mar 2021 --> Jun 2021
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial initiation date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Apr 5, 2019
P3, N=150, Not yet recruiting,
Trial completion date: Dec 2021 --> Mar 2022 | Initiation date: Sep 2019 --> Dec 2019 | Trial primary completion date: Mar 2021 --> Jun 2021 Trial completion date: May 2021 --> Dec 2021 | Initiation date: Apr 2019 --> Sep 2019
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date, Trial initiation date, Trial primary completion date: ANGLeD: ANG1005 in Leptomeningeal Disease From Breast Cancer (clinicaltrials.gov) - Jan 9, 2019
P3, N=150, Not yet recruiting,
Trial completion date: May 2021 --> Dec 2021 | Initiation date: Apr 2019 --> Sep 2019 Trial completion date: Jan 2021 --> May 2021 | Initiation date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2020 --> Apr 2021
- |||||||||| Review, Journal: Current challenges in the management of breast cancer brain metastases. (Pubmed Central) - Sep 30, 2017
The utility of human epidermal growth factor 2 (HER2)-directed therapies-lapatinib, ado-trastuzumab emtansine (T-DM1), neratinib and tucatinib-is also being studied in this setting...However, in selected circumstances, first-line systemic treatment may be more appropriate in order to avoid neurocognitive toxicities, and potential options should be evaluated in window of opportunity trials. Other strategies that may aid development of more effective clinical trials and expedite the development of promising agents include the use of different clinical endpoints and different imaging tools.
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion, Enrollment change: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (clinicaltrials.gov) - Sep 28, 2017
P2, N=72, Completed,
Other strategies that may aid development of more effective clinical trials and expedite the development of promising agents include the use of different clinical endpoints and different imaging tools. Active, not recruiting --> Completed | N=56 --> 72
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion, Trial primary completion date: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Sep 28, 2017
P2, N=73, Completed,
Active, not recruiting --> Completed | N=56 --> 72 Active, not recruiting --> Completed | Trial primary completion date: Dec 2017 --> Sep 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Aug 10, 2017
P2, N=83, Active, not recruiting,
Active, not recruiting --> Completed | Trial primary completion date: Dec 2017 --> Sep 2017 Trial primary completion date: Jul 2017 --> Dec 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (clinicaltrials.gov) - Apr 27, 2017
P2, N=56, Active, not recruiting,
Trial primary completion date: Jul 2017 --> Dec 2017 Trial primary completion date: May 2017 --> Oct 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Apr 27, 2017
P2, N=83, Active, not recruiting,
Trial primary completion date: May 2017 --> Oct 2017 Trial primary completion date: Mar 2017 --> Jul 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (clinicaltrials.gov) - Jan 12, 2017
P2, N=56, Active, not recruiting,
Trial primary completion date: Mar 2017 --> Jul 2017 Trial primary completion date: Sep 2016 --> May 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Jan 12, 2017
P2, N=83, Active, not recruiting,
Trial primary completion date: Sep 2016 --> May 2017 Trial primary completion date: Jun 2016 --> Mar 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (clinicaltrials.gov) - Jun 5, 2016
P2, N=56, Active, not recruiting,
Active, not recruiting --> Completed | Trial primary completion date: Apr 2016 --> Jun 2015 Trial primary completion date: Apr 2016 --> Sep 2016
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: GRN1005 for Brain Metastases From Breast or Lung Cancer (clinicaltrials.gov) - Feb 2, 2016
P2, N=0, Withdrawn,
Trial primary completion date: Apr 2016 --> Sep 2016 Trial primary completion date: Feb 2017 --> Aug 2014
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Jan 17, 2016
P2, N=83, Active, not recruiting,
Trial primary completion date: Feb 2017 --> Aug 2014 Trial primary completion date: Oct 2015 --> Jun 2016
- |||||||||| Herceptin (trastuzumab) / Roche, paclitaxel trevatide (ANG1005) / Angiochem
Enrollment closed, Trial primary completion date, Combination therapy: GRABM-B: GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (clinicaltrials.gov) - Apr 16, 2015
P2, N=80, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2014 --> Apr 2016
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Enrollment closed: ANG1005 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - Apr 14, 2015
P2, N=83, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2014 --> Apr 2016 Recruiting --> Active, not recruiting
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Enrollment change: ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases (clinicaltrials.gov) - Oct 11, 2014
P2, N=55, Recruiting,
N=50 --> 16 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Jan 2013; Slow recruitment N=40 --> 55
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Enrollment change, Trial withdrawal: GRN1005 for Brain Metastases From Breast or Lung Cancer (clinicaltrials.gov) - Aug 15, 2014
P2, N=0, Withdrawn,
Trial primary completion date: Jun 2014 --> Dec 2014 N=20 --> 0 | Suspended --> Withdrawn
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial primary completion date: GRN1005 for Brain Metastases From Breast or Lung Cancer (clinicaltrials.gov) - May 13, 2014
P2, N=20, Suspended,
N=20 --> 0 | Suspended --> Withdrawn Trial primary completion date: Jun 2014 --> Feb 2017
- |||||||||| paclitaxel trevatide (ANG1005) / Angiochem
Trial completion date: GRN1005 for Brain Metastases From Breast or Lung Cancer (clinicaltrials.gov) - May 13, 2014
P2, N=20, Suspended,
Trial primary completion date: Jun 2014 --> Feb 2017 Trial completion date: Jun 2014 --> Jun 2017
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