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Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

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Antineoplastic Agents

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Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Albumin-Bound Paclitaxel

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Tubulin Modulators

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Antimetabolites

Sirolimus

Temsirolimus

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Immunologic Factors

If patients were LAR subtype with HER2 gene activated mutation

If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation

If patients were IM subtype (CD8 positive T cell more than 10%)

If patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation

If patients were MES subtype and had PI3K/AKT/mTOR pathway activation

A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

A1: Pyrotinib with nab-paclitaxel

A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

A2: nab-paclitaxel

B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

B1: everolimus with nab-paclitaxel

B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

B2: nab-paclitaxel

C1: PD-1 antibody SHR1210 200mg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt + famitinib 20mg po qd, 4 weeks as a cycle

C1: PD-1 with nab-paclitaxel and famitinib

C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

C2: nab-paclitaxel

D1: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.

D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

D2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.

D2: nab-paclitaxel, with maintenance of capecitabine

E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

E1: everolimus with nab-paclitaxel

E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

E2: nab-paclitaxel

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.

An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)

Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.

Refers to the period from the date of the first study dose to the date of death for any reason.

Defined as the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of CR and PR.

Defined as the date from the first recording of tumor response (assessed according to RECIST 1.1) to the first recording of the objective progression of the tumor (assessed according to RECIST 1.1) or to the date of death for any reason, whichever occurs first.

The proportion of subjects who received treatment and whose best overall response (BOR) was assessed as complete response (CR), partial response (PR) and stable disease (SD) ≥4 weeks according to RECIST1.1.

AE refers to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTC AE 5.0.

Fudan University

Director of General Surgery of Fudan Shanghai Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Screening study to find out if Patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body are eligible to take part in 1 of 4 different research studies.

A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).

Tumor Biopsy

Vali Papadimitrakopoulou, MD

This trial is referred to as the "umbrella trial". The BATTLE program consists of this umbrella trial plus four phase II protocols into which the umbrella patients are enrolled. Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker analysis that will be used to assign them to one of the four phase II studies. All patients enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.

This study is the "umbrella" or screening study in a group of 5 studies known as the BATTLE (Biomarker-integrated Approaches of Targeted Therapy of Lung Cancer Elimination) program. In order to participate in one of the research studies, you must first agree to take part in this screening study, which will be used to determine if you are eligible. After participating in this study, you may be assigned to a study that is using an investigational drug. The investigational drug(s) to be used in each of the 4 studies are not approved by the Food and Drug Administration (FDA) for commercial use in this setting; however, the FDA has permitted its use in these research studies.

If you agree to participate in this screening study, your complete medical history (including smoking history) will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate), height, and weight. You will have blood (about 2 teaspoons) drawn for routine tests. You will also have blood (about 1-2 tablespoons) drawn to check your blood clotting function, thyroid function, and lipid (fat) levels. You will have a urine test, a performance status evaluation (questions about your ability to perform everyday activities), and an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

Your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. You will have a brain MRI. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test before receiving the study drug.

A sample of your tumor tissue will be collected for biomarker analysis. If your tumor tissue cannot be reached, you will not be able to participate in this research study. To collect a tumor biopsy, you will have either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node). You will be asked to stop taking any medication that affects blood-clotting (such as aspirin or coumadin) before the biopsy procedure.

For the cutaneous (skin) biopsy, you will be given a local anesthetic by either a spray or shot to numb your skin. A small cut will be made to remove all or a piece of the affected skin.

For the CT-guided core biopsy of the lung, subcutaneous, and/or lymph node biopsy, a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe. The needle is guided while being viewed by the physician on a CT scan. Any site that can be safely biopsied will be considered for the collection of tissue. Sites not commonly biopsied include kidneys, adrenal glands, and brain.

For the bronchoscopy, you will be given drugs to relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. A small brush will be fed through the tube and into your lungs. The brush will gently scrape off a sample of lung tissue. Tweezers will then be fed through the tube to collect the tissue samples (biopsy). A small amount of water will be sprayed into your lungs and then suctioned out through the tube to collect tissue samples and mucous samples.

For the CT-guided core biopsy or bronchoscopy, you should not take any medications by mouth or have any solid food for at least 6 hours before the procedure. You also should not have any liquids 2 hours before the procedure.

If you are eligible to take part in this study, you will be assigned to 1 of the 4 research studies based on the results of your tumor analysis. You will be asked to read and sign a separate informed consent to take part in one of the research studies.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.

This is an investigational study. Up to 250 patients will take part in this study. All will be enrolled at M. D. Anderson.

A sample of your tumor tissue will be collected for biomarker analysis, and based on the results, you will be assigned to one of four phase II studies.

BATTLE Program: Umbrella Protocol for Patients With Non-Small Cell Lung Cancer (NSCLC)

A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

United States Department of Defense

M.D. Anderson Cancer Center

Carboplatin

Letrozole

Goserelin

Pertuzumab

Androgen Receptor Antagonists

6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status.

2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery

If patients were HR+ and HER2- without PI3K-AKT pathway mutation

If patients were HR+ and HER2- with PI3K-AKT pathway mutation

If patients were HR+ and HER2+ without PI3K-AKT pathway mutation

If patients were HR+ and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2+ without PI3K-AKT pathway mutation

If patients were HR- and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2- with LAR subtype

HR+ and HER2-; No correlated pathway variation

TNBC with Homologous Recombination Repair Defect (HRD)

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles.

Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles.

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); Alpelisib 300mg PO QD； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH1

Drug:

oral letrozole 2.5 mg daily; Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH2

Drug:

pyrotinib(EGFR-TKI) 400mg qd； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； capecitabine 1000mg/m2 bid(d1-d14)

Drug:

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg po.qd(three week on one week off) SHR3680（AR inhibitor）240 mg po. qd.

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); oral letrozole 2.5 mg daily； Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause：Goserelin 3.6mg IM IM Q4W.

Famitinib 20mg orally once daily; Albumin paclitaxel 100mg/ m2, i.v.; Combined carboplatin AUC=2, i.v.; d1, 8, 15,21 days a cycle, a total of 4 cycles.

Fluzoparil 150mg orally twice daily; Famitinib 20mg orally once daily;

Adebrelimab was administered intravenously, 600mg each time, once every 2 weeks; Famitinib 20mg once daily; Albumin paclitaxel 100mg/m2 qw intravenous drip (used for 3 weeks/stopped for 1 week), 28 days per treatment cycle;

Zhimin Shao, MD.PhD.

Zhimin Shao, PhD

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.

pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.	NCT04395989	TNBC - Triple-N...	A1: Pyrotinib w... A2: nab-paclita... B1: everolimus ... B2: nab-paclita... C1: PD-1 with n... C2: nab-paclita... D1: VEGFR and n... D2: nab-paclita... E1: everolimus ... E2: nab-paclita...	18 Years - 70 Years	Fudan University
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.	NCT04395989	TNBC - Triple-N...	A1: Pyrotinib w... A2: nab-paclita... B1: everolimus ... B2: nab-paclita... C1: PD-1 with n... C2: nab-paclita... D1: VEGFR and n... D2: nab-paclita... E1: everolimus ... E2: nab-paclita...	18 Years - 70 Years	Fudan University
BATTLE Program: Umbrella Protocol for Patients With Non-Small Cell Lung Cancer (NSCLC)	NCT00409968	Lung Cancer	Tumor Biopsy	18 Years -	M.D. Anderson Cancer Center
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University

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