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Breast > HER2 IHC 0 metastatic breast cancer

Clinical trial information


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Area under investigation,BRCAm or PALB2m breast cancer,HER2 IHC 0 metastatic breast cancer=true,HER2-low breast cancer,HER2-positive breast cancer,HR-positive/HER2-negative breast cancer,TNBC

BLUESTAR trial overview

Tumor

Advanced solid tumors (breast cancer, BTCs, ovarian cancer, endometrial cancer, squamous NSCLC)

Trial Identifier

NCT05123482

Phase

I/IIa

Regimen

Puxitatug samrotecan monotherapy; puxitatug samrotecan + rilvegostomig; puxitatug samrotecan + rilvegostomig + palacaparib

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CAMBRIA-1 trial overview

Tumor

HR+/HER2- eBC with intermediate/high risk for disease recurrence and post definitive locoregional therapy and adjuvant ET for ≥2 and up to 5 years

Trial Identifier

NCT05774951

Phase

III

Regimen

Camizestrant; standard endocrine therapy of investigator's choice (aromatase inhibitors or tamoxifen)

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CAMBRIA-2 trial overview

Tumor

HR+/HER2- eBC with intermediate-high or high risk for disease recurrence after completion of definitive locoregional therapy (with or without chemotherapy)

Trial Identifier

NCT05952557

Phase

III

Regimen

Camizestrant ± abemaciclib; standard endocrine therapy of investigator's choice ± abemaciclib

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CAPItello-292 trial overview

Tumor

HR+/HER2-negative locally advanced or metastatic breast cancer relapsing on or within 12 months of completing adjuvant ET

Trial Identifier

NCT04862663

Phase

Ib/III

Regimen

Phase Ib - capivasertib + fulvestrant + CDK4/6i (palbociclib or ribociclib or abemaciclib); Phase III - fulvestrant + (palbociclib or ribociclib) ± capivasertib

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CYCAD-1 trial overview

Tumor

HR+/HER2- advanced breast cancer, metastatic high-grade serous ovarian cancer

Trial Identifier

NCT06188520

Phase

I/IIa

Regimen

AZD8421; AZD8421 + camizestrant + abemaciclib; AZD8421 + camizestrant + ribociclib; AZD8421 + camizestrant + palbociclib

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DESTINY-Breast09 trial overview

Tumor

HER2+ Advanced or metastatic breast cancer

Trial Identifier

NCT04784715

Phase

III

Regimen

T-DXd  ± pertuzumab; trastuzumab + pertuzumab + a taxane (investigator's choice of docetaxel or paclitaxel)

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fam-trastuzumab deruxtecan-nxki in US only; trastuzumab deruxtecan in other regions of world.

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DESTINY-Breast15 trial overview

Tumor

HER2-low or HER2 IHC 0 unresectable or metastatic breast cancer

Trial Identifier

NCT05950945

Phase

III

Regimen

T-DXd

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fam-trastuzumab deruxtecan-nxki in US only; trastuzumab deruxtecan in other regions of world.

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EvoPAR-Breast01 trial overview

Tumor

Advanced HR+/HER2- breast cancer with germline or somatic mutations in BRCA1/2 or PALB2 genes

Trial Identifier

NCT06380751

Phase

III

Regimen

Saruparib + camizestrant; physician’s choice CDK4/6i + physician’s choice endocrine therapy; physician’s choice CDK4/6i + camizestrant

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PETRA trial overview

Tumor

Advanced solid tumors (advanced/metastatic ovarian cancer, HR+/HER2- breast cancer, TNBC, pancreatic cancer, prostate cancer, NSCLC, SCLC, gastric cancer, biliary cancer, cervical cancer, endometrial cancer, CRC, bladder cancer)

Trial Identifier

NCT04644068

Phase

I/IIa

Regimen

Saruparib; saruparib + paclitaxel; saruparib + carboplatin ± paclitaxel; saruparib + T-DXd; saruparib + Dato-DXd; saruparib + camizestrant

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fam-trastuzumab deruxtecan-nxki in US only; trastuzumab deruxtecan in other regions of world.

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SERENA-4 trial overview

Tumor

HR+/HER2- advanced/metastatic breast cancer, 1L

Trial Identifier

NCT04711252

Phase

III

Regimen

Camizestrant + palbociclib; anastrozole + palbociclib

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SubQ (NCT07015697) trial overview

Tumor

HER2-expressing metastatic solid tumors

Trial Identifier

NCT07015697

Phase

I

Regimen

Subcutaneous T-DXd + hyaluronidase

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fam-trastuzumab deruxtecan-nxki in US only; trastuzumab deruxtecan in other regions of world. This study is sponsored by Daiichi Sankyo, Inc.

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TROPION-Breast03 trial overview

Tumor

TNBC (Stage I-III) who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy

Trial Identifier

NCT05629585

Phase

III

Stage

Stage I-III

Regimen

Dato-DXd ± durvalumab; investigator's choice of therapy (capecitabine or pembrolizumab or capecitabine + pembrolizumab)

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TROPION-Breast04 trial overview

Tumor

Histologically confirmed Stage II or III primary invasive TNBC or HR-low/HER2- BC

Trial Identifier

NCT06112379

Phase

III

Stage

Stage II-III

Regimen

Neoadjuvant Dato-DXd + durvalumab followed by adjuvant durvalumab ± olaparib (if gBRCAm) or CT; neoadjuvant pembrolizumab + CT followed by adjuvant pembrolizumab ± olaparib or capecitabine

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TROPION-Breast05 trial overview

Tumor

Locally recurrent inoperable or metastatic PD-L1-positive TNBC not previously treated with chemotherapy or targeted systemic anticancer therapy in this setting

Trial Identifier

NCT06103864

Phase

III

Stage

Stage IV

Regimen

Dato-DXd + durvalumab; investigator's choice of CT (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) with pembrolizumab; Dato-DXd monotherapy

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TROPION-Breast06 trial overview

Tumor

HR-positive/HER2 IHC 0, locally advanced inoperable or mBC refractory to ET

Trial Identifier

NCT07205822

Phase

IIIb

Stage

Stage IV

Regimen

Dato-DXd

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TROPION-PanTumor01 trial overview

Tumor

Advanced solid tumors including advanced/metastatic NSCLC, TNBC, HR-positive/HER2-negative breast cancer, HER2-low breast cancer, and other solid tumors

Trial Identifier

NCT03401385

Phase

I

Regimen

Dato-DXd

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This study is sponsored by Daiichi Sankyo, Inc.

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Veeva ID: Z4-84958 US-109129 DE-92568 Last Updated October 20263/26
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