Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Xin Du, MD

The primary objective of this study is to describe the maintenance of the molecular remission after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML) patients in China in the real-world clinical practice setting. This is a post-marketing, non-interventional, single-arm, prospective registry study in adult patients with chronic phase (CP) and accelerated phase (AP) in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Tyrosine kinase inhibitors (TKIs) are the standard of care for patients with chronic myeloid leukaemia (CML) in chronic phase. Imatinib, the first ATP competitive TKI, received approval for use based on a dramatic and durable survival benefit. Other TKIs, the second generation compounds dasatinib, nilotinib and bosutinib and the third generation drug ponatinib, were designed and tested for a greater target-specific potency. With the development of these effective TKI treatments, CML disease burden can be reduced to minimal levels, and CML patients can have a life expectancy similar to that of the general population. Although TKI treatment may result in a deep, stable molecular remission, CML treatment guidelines recommend that patients continue TKI treatment indefinitely. However, Chronic TKI therapy can cause drug-related adverse reactions and constitute financial difficulties, which can result in decreased adherence to therapy. Therefore, the concept of a lifelong therapy with TKIs has thus been challenged and treatment-free remission (TFR) strategies will soon integrate clinical practice.TFR can be defined as the ability to maintain molecular remission without taking any TKI therapy. Studies have demonstrated the feasibility of successful TFR. In the STIM and TWISTER trials, imatinib discontinuation was proposed providing that patients had achieved deep molecular response for a certain period. The 2-year probability to maintain such deep molecular response levels without any TKI therapy was 38% in STIM and 47% in TWISTER. Subsequently, several studies were conducted and confirmed that imatinib-free remission was possible. Discontinuation of new generation TKIs was also investigated and indicated that dasatinib or nilotinib may promote access to TFR strategies as compared to imatinib. TFR is on the way to become an important goal in clinical practice, implicating an alternation in CML management guidelines in the near future.

TKI Discontinuation in CML Patients of China

Tyrosine Kinase Inhibitor Discontinuation in Adults Patients With Chronic Myeloid Leukemia in China

Incidence of Treatment-free related Adverse Events

Shenzhen Second People's Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Trastuzumab

Antineoplastic Agents, Immunological

Herceptin (trastuzumab)

SB3 (proposed trastuzumab biosimilar)

A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%

Samsung Bioepis Co., Ltd.

For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.

Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Herceptin (Trastuzumab)

Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

SB3 (Proposed Trastuzumab Biosimilar)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Director of Clinical Trials

Intravenous administration

Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Intravenous administration

SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Number of Subjects With Asymptomatic Significant LVEF Decrease

Overall Study

Hormones

Fulvestrant

Estrogens

Anastrozole

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Aromatase Inhibitors

Enzyme Inhibitors

intramuscular injection 250 mg loading dose (LD) regimen

Roger Henriksson, MD

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.

No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders

Time from randomisation until the date of discontinuation of randomised treatment for any reason

Overall survival is equivalent to time to death. Time from randomisation until the date of death

AstraZeneca

Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg

Fulvestrant + Anastrozole

Age Continuous

Gerard Lynch

Time to Progression (TTP)

Percentage of Evaluable Participants With Objective Response Rate (ORR)

Percentage of Clinical Benefit Rate (CBR) Responders

Duration of Response (DoR)

Duration of Clinical Benefit (DoCB)

Time to Treatment Failure (TTF)

Overall Survival (OS)

Bone Density Conservation Agents

Tamoxifen

Exemestane

Aromasin

Pfizer CT.gov Call Center

The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.

This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).

An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.

Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.

Age, Continuous

Ductal Carcinoma

Lobular Carcinoma

Invasive Ductal Carcinoma

Invasive Lobular Carcinoma

Papillary Carcinoma

Medullary Carcinoma

Mucinous (Colloid) Carcinoma

Other

Missing/No Response

Number of participants with different types of tumor such as; ductal carcinoma, lobular carcinoma, invasive ductal carcinoma, invasive lobular carcinoma, papillary carcinoma, medullary carcinoma, mucinous (colloid) carcinoma and others.

Number of Participants With Type of Tumor

Appendicectomy

Breast lump removal

Cataract operation

Cholecystectomy

Hysterectomy

Intervertebral disc operation

Malignant tumor excision

Salpingo-oophorectomy bilateral

Splenectomy

Number of participants who had undergone different type of surgeries which included appendicectomy, breast lump removal, cataract operation, cholecystectomy, hysterectomy, intervertebral disc operation, malignant tumor excision, salpingo-oophorectomy bilateral, and splenectomy.

Number of Participants With Type of Surgery

Participants whose tumor was estrogen receptor positive are reported.

Number of Participants With Estrogen Receptor Positive

Number of Participants With Lymph Node Involvement

Stage I

Stage IIA

Stage IIB

Stage IIIA

Stage IIIB

Stage IIIC

TNM was based on size of tumor, if cancer cells had spread to nearby lymph nodes (LN), or distant (to other parts of the body) metastasis had occurred. Stages included: stage 0(no evidence of cancer cells), stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0), stage IIIC(any TN3M0), stage IV(anyT anyNM1), where T0=early form of tumor, T1= \<2 centimeter(cm), T2=2-5 cm, T3= \>2 cm, T4=large sized tumor, N0=not spread to LN, N1=spread to 1 to 3, N2=spread to 4 to 9, N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Number of Participants With Tumor Node Metastasis (TNM) Stage

Grade 1

Grade 2

Grade 3

Unknown

The grade of a cancer depends on what the cells look like and the growth-rate. Lower grade indicates a slower-growing cancer and a higher grade indicates a faster-growing one. Grade 1 (resemble normal cells, not growing rapidly), Grade 2 (grow faster than normal cells), Grade 3 and 4 (abnormal cells, grow and spread aggressively).

Number of Participants With Histopathological Grade

Number of Participants With Prior Chemotherapy

A total 271 participants were evaluable for this measure.

Number of Participants With Prior Radiation Therapy

The study was prematurely terminated on 31 August 2012 due to unexpected high rate of participant withdrawal caused by Aromasin reimbursement policy change in Romania. There were no safety issues related to study termination.

Pfizer ClinicalTrials.gov Call Center

Grade 4

Grade 5

Missing or Unknown

Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.

Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity

AEs (All Causalities)

SAEs (All Causalities)

AEs (Treatment Related)

SAEs (Treatment Related)

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug

Week 25 (n=18)

Week 49 (n=8)

Week 73 (n=5)

Week 97 (n=4)

Week 121 (n=4)

Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.

Number of Missed Exemestane Doses

Adverse event

Insufficient clinical response

Did not meet entrance criteria

Lost to follow-up

No longer willing to participate in study

Other unspecified

Protocol violation

Study terminated by sponsor

Withdrawn due to pregnancy

Number of Participants With Reasons for Discontinuing Exemestane Therapy

Received hormonal therapy

Received chemotherapy

Received both hormonal and chemotherapy

No hormonal or chemotherapy received

Missing or no response

FAS included all participants who had received at least 1 dose of exemestane during the observation period.

Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy

Percentage of Participants Who Discontinued the Exemestane Therapy

A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.

Recurrence-free Survival (RFS)

Time to disease progression was considered complementary to RFS and hence, was not analyzed.

Time to Disease Progression (TTP)

Neoplasm Metastasis

Bevacizumab

Angiogenesis Inhibitors

Growth Inhibitors

bevacizumab combined with dose dense chemotherapy

Linnea I. Chap, MD

Marilyn Mulay, MSN

Linnea I. Chap, M.D.

This research focuses on women with breast cancer whose disease has not significantly progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in combination with a regimen of approved chemotherapy drugs known as "dose dense chemotherapy." The study will observe the effectiveness and tolerability of this regimen.

Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.

Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof that one regimen is superior to another. Therefore, in an attempt to decrease metastases, prolong time to recurrence and improve overall survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of angiogenesis represents a promising option.

Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment of colon cancer. It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy.

This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab alone. Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TKI Discontinuation in CML Patients of China	NCT03251352	Leukemia Myelogenous Chronic BCR-ABL (Breakp... Positive		18 Years -	Shenzhen Second People's Hospital
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy	NCT00256698	Breast Cancer	Fulvestrant Anastrozole	-	AstraZeneca
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer	NCT01121549	Invasive Early ...	Aromasin	-	Pfizer
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer	NCT01121549	Invasive Early ...	Aromasin	-	Pfizer
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy	NCT00256698	Breast Cancer	Fulvestrant Anastrozole	-	AstraZeneca
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.
Brentuximab Vedotin in CD30 Positive Epstein Barr Virus (EBV) Positive DLBCL of Elderly	NCT01671813	Lymphoma	brentuximab ved...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for positive

Every month we try and update this database with for positive 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 positive

Every month we try and update this database with for positive 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 positive 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.