Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Endometrial Neoplasms

Breast Diseases

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Tislelizumab

Antineoplastic Agents, Immunological

Cola

Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period

Patients will be enrolled to one of the following expansion cohorts:

* Cohort A: TNBC (immuno-oncology \[IO\]-treated in the metastatic setting)
* Cohort B: TNBC (IO-Naïve in the metastatic setting)
* Cohort C: EC
* Cohort D: MSS CRC

Fruquintinib

William Schelman, MD, PhD

This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2).

The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase.

* Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated)
* Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve)
* Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve)
* Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)

A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors

An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors

To assess the safety and tolerability by monitoring AEs characterized by type, frequency, severity per NCI-CTCAE v5.0

To confirm the RP2D of fruquintinib in combination with tislelizumab

To evaluate the objective response rate (ORR) as assessed by the investigator in subjects with advanced or metastatic TNBC or EC or CRC when treated with fruquintinib in combination with tislelizumab

Blood samples will be taken to measure levels of fruquintinib

Blood samples will be taken to measure levels of tislelizumab

To further evaluate efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic TNBC or EC per investigator assessment

To detect the expression biomarkers in tumor tissues of patients

To evaluate the immunogenicity of fruquintinib in combination with tislelizumab

The incidence of complete response, partial response, and stable disease

The incidence of partial response and stable disease

he duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recroded

The period from date of enrollment to date of death

BeiGene

Hutchison Medipharma Limited

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Estrogens

Cisplatin

Mitogens

Progesterone

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

cisplatin

Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

bevacizumab

Postoperative: Given intravenously for four 2-week cycles

doxorubicin

Postoperative: Given intravenously for four two-week cycles

cyclophosphamide

Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

paclitaxel

Paula D. Ryan, MD

The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.

* To prepare for surgery, a small "clip" will be placed into the tumor area so that the surgeon can locate the site of the tumor at the time of surgery. This is a standard procedure for breast cancer.
* The study drugs will be given in four 3-week cycles (about 3 months). Participants will come into the clinic each day they receive study treatment intravenously. Cisplatin will be given on day one of the treatment cycle (once every 3 weeks) for four cycles. Bevacizumab will be given on day one of the treatment cycle for three cycles.
* On day one of each 3-week cycle a physical exam, routine blood tests and urine test will be performed. 7-8 days after chemotherapy, blood tests and a hearing test will be performed. A preoperative study visit will take place 7-10 days before surgery and a physical exam, routine blood tests, Electrocardiogram (EKG) and an Magnetic Resonance Imaging (MRI) of the breast will be performed.
* Surgery to remove the tumor will occur at least three weeks after the last dose of cisplatin and is considered standard of care.
* Postoperative chemotherapy will begin at least three weeks after surgery. Everyone on the research study will receive four 2-week cycles of doxorubicin and cyclophosphamide plus bevacizumab. After the 8 weeks, the doctor will decide which of the following two treatment regimens the participant will receive: Bevacizumab for four 2-week cycles (once every two weeks) or; Paclitaxel plus bevacizumab for four 2-week cycles (once every two weeks).
* At the end of the postoperative chemotherapy, the participant will return to the clinic for a medical history, physical exam, vital signs, performance status, routine blood tests, multiple gated acquisition scan (MUGA) or Echocardiogram Scans, and a hearing test.

Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer

A Phase II Trial of Preoperative Cisplatin and Bevacizumab in Estrogen Receptor (ER) Negative, Progesterone (PR) Negative, Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.

To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Genentech, Inc.

Massachusetts General Hospital

Steven Isakoff, MD, PhD

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Cisplatin/Avastin

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

stage 2 or 3 triple negative breast cancer

Dr. Steven Isakoff

Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.

OR = CR+PR

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab

analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment

Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.

Patients With Miller-Payne (MP) Score 3, 4, or 5 Response

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Overall Study

Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment

Tumour bed core biopsy

Daniel Rea

A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies

The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.

NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer

Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?

The observed number of patients with false negative biopsies (i.e. no tumour in the biopsy but tumour in the surgical specimen) as a proportion of all those assessed by Local Histopathology Review

is defined as the number of patients whose initial local pathological assessment of pCR is confirmed by Central Histopathology Review

assessed by calculating relative dose intensity taking into account of both reductions in dose and delays to treatment.

Compliance with neoadjuvant and adjuvant treatment; will be assessed by calculating relative dose intensity taking into account of both reductions in dose and delays to treatment.

defined in whole days from date of registration to distant recurrence or death from any cause. Patients who are alive and without distant recurrence at the time of analysis will be censored at the date last seen.

defined in whole days as the date of registration to death from any cause. Patients alive at the time of analysis will be censored at the date last seen.

This will be reported as a proportion of all recruited patients

Sensitivity, specificity and false negative rates will be reported.

Roche Pharma AG

Cancer Research UK

University of Birmingham

Carboplatin

NK012 and carboplatin via infusion once every 28 days

NK012 and carboplatin

Howard Burris, MD

The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.

NK012 will be administered as a 30 minute IV infusion, followed by a 30 minute carboplatin IV infusion. Both drugs will be administered once every 28 days. Treatment is expected to continue for 6 cycles, unless disease progression or the development of unacceptable toxicity requires discontinuation of the drug. At the discretion of the investigator, patients who show signs of benefit may continue beyond 6 cycles.

Once a MTD/RD has been determined, a dose expansion cohort of patients with metastatic triple negative breast cancer will be treated at the determined MTD.

Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer

A Phase I Study of NK012 in Combination With Carboplatin in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Triple Negative Metastatic Breast Cancer

Efficacy, based on RECIST 1.1, will be assessed in all solid tumors, and in a specific subset of patients with breast cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors	NCT04577963	Triple Negative... Endometrial Can... Solid Tumor, Un... Colorectal Canc...	Fruquintinib Tislelizumab	18 Years -	Hutchmed
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors	NCT04577963	Triple Negative... Endometrial Can... Solid Tumor, Un... Colorectal Canc...	Fruquintinib Tislelizumab	18 Years -	Hutchmed
Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer	NCT00580333	Breast Cancer	cisplatin bevacizumab doxorubicin cyclophosphamid... paclitaxel	18 Years -	Massachusetts General Hospital
NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer	NCT04118192	Breast Cancer	Tumour bed core...	18 Years -	University of Birmingham
Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer	NCT01238952	Advanced Solid ... Metastatic Trip...	NK012 and carbo...	18 Years -	Nippon Kayaku Co., Ltd.

Spots Global Cancer Trial Database for er negative

Every month we try and update this database with for er negative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for er negative

Every month we try and update this database with for er negative cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for er negative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.