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BREAST: EARLY STAGE Breast Conservation Selene Margin status

A prospective, multi-center, randomized, double-arm trial to determine the impact of the SELENE system on positive margin rates in breast conservation surgery

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Malignancy

Breast

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Selene

Drug Class

Optical Coherence Tomography (OCT)

PI

Richard Fine, MD

Sponsor

PERIMETER

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
  • May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Male
  • Metastatic cancer (Stage IV)
  • Lobular carcinoma as primary diagnosis
  • Previous ipsilateral breast surgery for benign or malignant disease (this includes implants and breast augmentation)
  • Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
  • Subjects with bilateral disease (diagnosed cancer in both breasts)
  • Participating in any other investigational margin assessment study which can influence collection of valid data under this study
  • Use of cryo-assisted localization
  • Currently lactating
  • Current pregnancy
  • Subjects undergoing breast conserving surgery whose resected specimen will be evaluated with intraoperative pathology, frozen section, or imprint cytology
BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
  • ER/PR <10%, HER2 negative
  • ECOG PS 0-1
  • ANC >1200, Hgb >10, Plt >100,000
  • Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
  • No T3 or T4 tumors
  • No definitive surgical treatment performed yet
  • No evidence of metastatic disease
  • No prior history of ipsilateral DCIS or breast cancer
  • No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
  • No other malignancies within 2 years prior
  • No active cardiac disease
  • No uncontrolled hypertension
  • No known HIV/HBV/HCV
  • No neuropathy grade >=2
BREAST: EARLY STAGE: HER2 POSITIVE: POST-NEOADJUVANT: RESIDUAL CANCER: ASTEFANIA

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

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Malignancy

Breast cancer, HER2 positive

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Roche/Genentech

Path

HER2 positive early breast cancer

Key Eligibility Criteria Details
  • HER2 positive invasive breast cancer
  • Stage at disease presentation: any cT2-4, any cN1-3, M0
    • Patients with cT1-3N0-1/M0 at presentation must have pathologic evidence of residual cancer in the axilla at time of surgery
    • Patients with T4 or N2-3 disease must have pathologic evidence of residual cancer in either the breast and/or the axilla
  • Completion of at least 6 cycles and 16 weeks of pre-operative systemic chemotherapy including 9 weeks of a taxane and 9 weeks of trastuzumab
  • Cannot have had a best response to neoadjuvant therapy of progressive disease
  • < or = 12 weeks since primary surgery and randomization
  • ECOG PS 0-1
  • LVEF >or = 50%
  • No prior T-DM1 or immune checkpoint inhibitors
  • Documentation of PD-L1 status
BREAST: ADJUVANT: TNBC: POST-NEOADJUVANT: TROPION-Breast03

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

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Malignancy

Breast, Triple negative breast cancer, TNBC

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

datopotamab deruxtecan (Dato-DXd)

Drug Class

ADC, Trop2 with Topo1 inhibitor payload

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

Triple negative, ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Histologically confirmed TNBC, Stage I-III
  • Residual invasive disease in the breasat and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy
  • Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab
  • No evidence of locoregional or distant relapse
  • Surgical removal of all clinically evident disease
  • ECOG PS 0-1
  • No adjuvant systemic therapy
  • LVEF > 50%
  • No known germline BRCA mutation
  • No Stage IV disease
  • No history of prior invasive breast cancer
  • No persistent toxicities from prior anticancer therapies
  • No prior autoimmune or inflammatory disorders
  • No known HIV
BREAST: METASTATIC: ER+: PRIOR CDK4/6: evERA trial

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

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Malignancy

Breast Cancer, MBC, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line endocrine

Investigational Agent

Giredestrant

Drug Class

SERD

PI

Greg Vidal, MD, PhD

Sponsor

Genentech, Inc.

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • Metastatic or locally advanced breast cancer not amenable to treatment with curative intent
  • ER+, HER2-
  • Prior endocrine therapy in combination with CDK 4/6 in either metastatic setting with disease progression after 6 months or in the adjuvant setting with relapsed disease within 12 months of exposure. (patients must have taken at least 12 months of adjuvant endocrine therapy, of which 6 months were in combination with a CDK4/6 inhibitor)
  • Measurable disease or evaluable bone mets
  • ECOG PS 0-1
  • For premenopausal or perimenopausal women or men must have treatment with LHRH agonist therapy for duration of study
  • No prior treatment with oral SERD, SERM, or everolimus. Fulvestrant is allowed if tx stopped at least 28 days prior to randomization
  • No more than 2 prior lines of systemic endocrine therapy in metastatic setting
  • No prior chemotherapy in metasatic setting
  • No other malignancy within 5 years except nonmelanoma skin cancer, papillary thyroid cancer, or very low risk of recurrence cancers
  • No known active CNS mets
BREAST: METASTATIC: HER2+: ER+: 1st Line: heredERA

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st

Investigational Agent

Giredestrant, Phesgo, taxane

Drug Class

SERD, anti-HER2

PI

Saradasri Wellikoff, MD

Sponsor

Roche

Path

HER2 positive, ER positive

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
  • Evaluable disease (measurable not required)
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
  • ECOG PS 0-1
  • LVEF of at least (≥)50%
  • No previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
  • No prior treatment with a selective estrogen receptor degrader (SERD)
  • No previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
  • No disease progression within 6 months of receiving trastuzumab, with or without pertuzumab, or ado-trastuzumab emtansine in the adjuvant setting
  • No history of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.
  • No known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  • No current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)
  • No history of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
BREAST: METASTATIC: HER2+:1ST LINE: DESTINY BREAST-09

Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab Deruxtecan

Drug Class

Anti-body drug conjugate against HER2

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

HER2+ (IHC 3+ or FISH+)

Key Eligibility Criteria Details
  • Advanced or metastatic breast cancer that is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) with known horme receptor status
  • No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.
  • No more than 1 previous line of endorcrine therapy in the metastatic setting
  • Adjuvant/neo-adjuvant therapy allowed if >6 months from treatment to metastatic diagnosis
  • ECOG PS 0-1
  • No clinically active CNS disease
  • No active ILD/pneumonitis
BREAST: METASTATIC: TNBC: 1st Line: ASCENT-03

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st or 2nd line

Investigational Agent

Sacituzumab govitecan-hziy

Drug Class

Trop-2 antibody drug conjugate

PI

Greg Vidal, MD, PhD

Sponsor

Gilead Sciences

Path

Triple negative; TNBC

Key Eligibility Criteria Details
  • Previously untreated locally advanced, inoperable, or metastatic TNBC (centrally confirmed)
    • Must be PD-L1 negative (centrally confirmed) unless treated in the adjuvant or neoadjuvant setting with PD-1 inhibitors, in which case they can be PD-L1 positive
  • Must have had at least 6 months between completion of treatment for curative intent and first documented local or distant disease recurrence (if treated for curative intent in the past)
  • Measurable disease
  • ECOG PS 0-1
  • No HIV
  • No active HBV/HCV
  • No previous topoisomerase inhibitors
BREAST: METASTATIC: TNBC: PD-L1+: 1st Line: ASCENT-04

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

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Malignancy

Breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Sacituzumab govitecan, pembrolizumab

Drug Class

Trop-2 antibody drug conjugate, PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Gilead Sciences

Path

TNBC, PD-L1 positive

Key Eligibility Criteria Details
  • Locally advanced, inoperable, or metastatic TNBC (centrally confirmed) without prior therapy for advanced disease
  • PD-L1 positive (centrally confirmed)
  • If patient received treatment for early disease, must have completed treatment at least 6 months prior to development of metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No prior topoisomerase inhibitors
  • No active autoimmune disease
  • If HIV positive may not have had Kaposi's sarcoma or Castleman's disease
  • No active HBV/HCV
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo

Drug Class

PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

ER- (negative), PR- (negative), HER2- (negative)

Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • 2nd line
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: PRECISION 1

A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.

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Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

PI

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details
  • Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
  • Metastatic or locally advanced solid tumors
  • Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
  • Measurable disease
  • ECOG PS 0-1
  • Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
  • No prior treatment with MTOR inhibitor
  • No primary brain tumors
  • No known HIV
ADVANCED SOLID TUMORS: RCC, Breast, Prostate, Bladder, CRC: STELLAR-001

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

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Malignancy

Renal cell carcinoma, hormone receptor positive breast cancer, castration-resistant prostate cancer, urothelial cancer, colorectal cancer (HR+ BC, RCC, CRPC, Bladder, CRC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Generally at least 1 prior line. Some exceptions

Investigational Agent

XL092

Drug Class

VEGF/MET kinase inhibitor

PI

Dan Vaena, MD

Sponsor

Exelixis

Path

Key Eligibility Criteria Details
  • Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
  • Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
  • Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum who received prior fluoropyrimidine-containing chemotherapy with oxaliplatin and irinotecan.
    • KRAS/NRAS wild type
    • Must have received all of the following: fluropyridmidine, irinotecan,  oxaliplatin,  EGFR monoclonal antibody, and, for those with BRAF mutation, BRAF inhibitor in combination with cetuximab
    • Must have progression during or within 3 months following the last dose of the most recent regimen
    • Prior therapy with regorafenib or TAS-102 are NOT allowed
  • Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
  • Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
  • Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
  •  Locally advanced, recurrent, or metastatic
  • No known untreated CNS mets
  • ECOG PS 0-1
ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
  • Must have tumor specimen available
  • Measurable disease
  • ECOG PS 0-1
  • Life expectancy at least 12 weeks
  • Phase 1a- must have exhausted all standard therapies for their disease
  • Phase 1b- must have disease that has progressed after at least one available standard therapy
  • Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
  • No active HBV/HCV or chronic or acute EBV
  • No history of autoimmune disease
  • No symptomatic or actively progressing CNS mets
ADVANCED SOLID TUMORS: LATE LINE: GLOBO-H POSITIVE: OBI-999-001

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

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Malignancy

Pancreatic, Esophageal, Gastric, Colorectal, Breast, Lung, Prostate, Melanoma, Head and Neck, Sarcoma, Bladder, Renal Cell, Ovarian, Endometrial, Cervical

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-999

Drug Class

Globo H targeting agent

PI

Dan Vaena, MD

Sponsor

OBI Pharma

Path

Any solid tumor

Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed patients with advanced solid tumors
  • Must have documented Globo H score of at least 100 from a qualified laboratory IHC assay
  • Must have been treated with established standard-f-care therapy or physicians have determined that such established therapy is not sufficiently efficacious or patients have declined to received standard-of-care therapy
  • ECOG PS 0-1
  • Measurable disease
  • Adequate organ function
  • No known untreated CNS mets
  • No significant clinical cardiac abnormality
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