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Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)

Status: Recruiting

Location: See location...

Intervention Type: Drug, Radiation

Study Type: Interventional

Study Phase: Phase 2

SUMMARY

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

Eligibility

Participation Requirements

Sex: Female

Minimum Age: 18

Maximum Age: 70

Healthy Volunteers: f

View:

• Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;

• Age between18-70 years;

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

• ER, PR and HER2 status were measured by immunohistochemistry (IHC);

• LVEF≥55%；

• Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices;

• Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;

• At least one measurable lesion according to RECIST version 1.1

• Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);

• Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;

• Ability to understand and willingness to sign a written informed consent

Locations

Other Locations

China

Fudan University Shanghai Cancer Center Shanghai, China, 200032

RECRUITING

Shanghai

Contact Information

Primary

Zhimin Shao, Professor

zhimingshao@yahoo.com

+86(021)64175590

Time Frame

Start Date: 2022-11-01

Estimated Completion Date: 2029-09

Participants

Target number of participants: 716

Treatments

Experimental: L1-1

If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype

Active_comparator: L1-2

If patients were HR+HER2- with SNF1 subtype

Active_comparator: L2-2

If patients were HR+HER2- with SNF2 subtype

Active_comparator: L3-2

If patients were HR+HER2- with SNF3 subtype

Active_comparator: L4-2

If patients were HR+HER2- with SNF4 subtype

Experimental: L4-low-1

If patients were HR+HER2-low with SNF4 subtype

Active_comparator: L4-low-2

If patients were HR+HER2-low with SNF4 subtype

Experimental: TN1-1

If patients were triple-negative breast cancer with immunomodulatory (IM) subtype

Active_comparator: TN1-2

If patients were triple-negative breast cancer with IM subtype

Experimental: TN2-1

If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype

Active_comparator: TN2-2

If patients were triple-negative breast cancer with BLIS subtype

Experimental: TN3-1

If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype

Active_comparator: TN3-2

If patients were triple-negative breast cancer with AR HER2 subtype

Experimental: TN4-1.1

If patients were HR-HER2-low

Active_comparator: TN4-2

If patients were HR-HER2-low

Experimental: TN5-1.1

If patients were triple-negative breast cancer with other subtypes

Active_comparator: TN5-2

If patients were triple-negative breast cancer with other subtypes

Experimental: H1-1.1

If patients were HR+HER2+

Active_comparator: H1-2

If patients were HR+HER2+

Experimental: H2-1.1

If patients were HR-HER2+

Active_comparator: H2-2

If patients were HR-HER2+

Experimental: L2-1.2

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Experimental: L3-1.2

If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype

Experimental: L4-1.2

If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype

Experimental: TN5-1.2

If patients were triple-negative breast cancer with other subtypes

Experimental: H1-1.2

If patients were HR+HER2+

Experimental: H2-1.2

If patients were HR-HER2+

Experimental: TN4-1.2

If patients were HR-HER2-low

Experimental: L2-1.1

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Experimental: L2-1.3

If patients were HR+HER2- with similarity network fusion 2 (SNF2) subtype

Experimental: L3-1.1

If patients were HR+HER2- with similarity network fusion 3 (SNF3) subtype

Experimental: L4-1.1

If patients were HR+HER2- with similarity network fusion 4 (SNF4) subtype

Experimental: L5-1

If patients were HR+HER2-

Experimental: L5-2

If patients were HR+HER2-

Experimental: L6

If patients were HR+HER2-low

Experimental: L7

If patients were HR+HER2-low

Experimental: L8

If patients were HR+HER2-

Experimental: L9

If patients were HR+HER2-low

Experimental: TN6-1

TNBC

Experimental: TN6-2

TNBC

Experimental: TN7-1

If patients were HR-HER2-low

Experimental: TN7-2

If patients were HR-HER2-low

Experimental: TN8

TNBC

Experimental: TN9

TNBC

Experimental: H3

If patients were HER2+

Experimental: H4-1

If patients were HER2+

Experimental: H4-2

If patients were HER2+

Experimental: H4-3

If patients were HER2+

Experimental: H4-4

If patients were HER2+

Experimental: H5

If patients were HER2+

Experimental: H6-1

If patients were HER2+

Experimental: H6-2

If patients were HER2+

Experimental: L10

If patients were HR+HER2-

Experimental: H8-1

If patients were HR+HER2+

Experimental: H8-2

If patients were HR+HER2+

Experimental: TN10

If patients were TNBC

Experimental: L11

If patients were HR+HER2-

Experimental: H9

If patients were HER2+

Experimental: H10

If patients were HER2+

Experimental: TN6-3

TNBC

Experimental: TN11-1: TNBC patients predicted sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI

The TN11 arm explores AI-guided multidisciplinary precision therapy in TNBC. Patients are stratified using an established digital pathology-based AI model that predicts sensitivity to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib. Patients predicted to be sensitive (TN11-1) receive this combination therapy directly.

Experimental: TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI

TNBC patients predicted to be non-sensitive (TN11-2) to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib first undergo stereotactic body radiation therapy (SBRT). SBRT is delivered to the primary tumor in 3 fractions of 8 Gy (total 24 Gy) over 3-5 days. Following SBRT, patients receive the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib.

Experimental: L12

Patients with HR+HER2- breast cancer, clinical stage cT1c-4, cN0-3, M0, with either tumor grade ≥2 or Ki-67 ≥20%. Patients first undergo stereotactic body radiotherapy (SBRT) to the primary tumor, followed by combination therapy of Paclitaxel + Epirubicin + Cyclophosphamide + Camrelizumab + Famitinib.

Related Therapeutic Areas

Trophoblastic Tumor Placental Site

Breast Cancer

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