Caroline Block

Feasibility and safety of avoiding granulocyte colony-stimulating

Submitted by shcAdmin on Wed, 12/19/2018 - 15:47
Study ID
DFCI 15-516
Status
Trial Conditions New
Study Information

Traditionally, Taxol chemotherapy administered every 2 weeks (called “dose dense”) includes Neulasta (Pegfilgrastim) the day after treatment to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time. In this research study, we are testing the safety and feasibility of delivering 4 cycles of dose-dense Taxol without the use of Neulasta as a growth factor support. We want to see if Neulasta is necessary during this phase of chemotherapy and if there are less side effects without its use. If you are found to need Neulasta (for example, because of low blood counts), the study has guidance for your study doctor for you to still be able to receive it.

Physician
Contact Information

Wendy Loeser RN OCN Clinical Research Dana-Farber Cancer Institute at St. Elizabeth's Medical Center 736 Cambridge St Boston, MA 02135 617-789-3385 Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
Are you a breast cancer patient who is about to start taxol treatment with an every 2-week schedule?

In this research study, we are testing the safety and feasibility of delivering 4
cycles of dose-dense Taxol chemotherapy without the use of Neulasta support.
Phase
2
Eligibility

 You are currently receiving or have completed 4 cycles of dose dense AC (Adriamycin/Cyclophosphamide) chemotherapy treatment.  Your blood counts meet the study criteria.  You are 18 to 64 years of age. You may not be eligible to participate if:  You had at least one episode of fever and neutropenia (low white blood cell counts) during the AC treatment.  You are receiving any investigational agents.  You are receiving any prohibited medications.  You are pregnant or nursing.  You have received other chemotherapy regimens in the last 5 years.

Trial conditions

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Submitted by shcAdmin on Wed, 12/19/2018 - 15:47
Study ID
DFCI 16-727
Status
Accepting Healthy Volunteers
Trial Conditions New
Study Information

This study has two study groups. Group 1 will receive the study drug, aspirin at 300 mg per day, which is a dose that is available over the counter without a prescription. Group 2 will receive a placebo, a pill that looks like the study drug, but contains no medication. Aspirin or placebo will be taken daily for 5 years. People who were recommended hormonal therapy will continue their hormonal therapy as directed.

• Visit www.abctrial.org for more information. • Contact Wendy Loeser, RN with any questions you may have.

Physician
Contact Information

Wendy Loeser RN OCN Clinical Research Dana-Farber Cancer Institute at St. Elizabeth's Medical Center 736 Cambridge St Boston, MA 02135 617-789-3385 Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
The purpose of this study is to determine if aspirin can prevent a recurrence of breast cancer or prevent the spread of breast cancer (metastatic breast cancer). Recent studies around the world have linked aspirin with a lower risk of death from cancer. This ABC Trial is the first U.S. study to test whether aspirin will keep breast cancer from recurring and reduce death from breast cancer.
Phase
3
Eligibility

• Women or men with node positive, HER2 negative, stage II or III breast carcinoma within one year of diagnosis and free of recurrence. •If any chemotherapy and/or endocrine therapy the last dose must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed. • Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. •Participants will be encouraged to use acetaminophen for minor pain and fever. •Patients must be enrolled within 1 year after diagnosis. •Age > 18 and < 70 years of age. •Platelet count ≥ 100,000/mm3 Exclusions: •No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention. • No history of any prior stroke • No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors. • No history of atrial fibrillation or myocardial infarction. • No history of grade 4 hypertension. •No chronic (duration >30 days) daily use of oral steriods. • No known allergy to aspirin. • No other cancer of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.

Feasibility and safety of avoiding granulocyte colony-stimulating

Submitted by aschwalb on Thu, 08/10/2017 - 14:15
Study ID
DFCI 15-516
Trial Conditions New
Study Information

Traditionally, Taxol chemotherapy administered every 2 weeks (called “dose dense”) includes Neulasta (Pegfilgrastim) the day after treatment to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time.

In this research study, we are testing the safety and feasibility of delivering 4
cycles of dose-dense Taxol without the use of Neulasta as a growth factor
support. We want to see if Neulasta is necessary during this phase of chemotherapy and if there are less side effects without its use.
If you are found to need Neulasta (for example, because of low blood counts), the study has guidance for your study doctor for you to still be able to receive it.

Physician
Contact Information

Wendy Loeser RN OCN
Clinical Research
Dana-Farber Cancer Institute at
St. Elizabeth's Medical Center
736 Cambridge St
Boston, MA 02135
617-789-3385
Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
Are you a breast cancer patient who is about to start taxol treatment with an every 2-week schedule?

In this research study, we are testing the safety and feasibility of delivering 4
cycles of dose-dense Taxol chemotherapy without the use of Neulasta support.
Phase
2
Ignore this field in update
Off
Eligibility

 You are currently receiving or have completed 4 cycles of dose dense AC (Adriamycin/Cyclophosphamide) chemotherapy treatment.

 Your blood counts meet the study criteria.

 You are 18 to 64 years of age.

You may not be eligible to participate if:

 You had at least one episode of fever and neutropenia (low white blood cell counts) during the AC treatment.

 You are receiving any investigational agents.

 You are receiving any prohibited medications.

 You are pregnant or nursing.

 You have received other chemotherapy regimens in the last 5 years.

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Submitted by aschwalb on Thu, 08/10/2017 - 14:05
Study ID
DFCI 16-727
Trial Conditions New
Study Information

This study has two study groups. Group 1 will receive the study drug, aspirin at 300 mg per day, which is a dose that is available over the counter without a prescription. Group 2 will receive a placebo, a pill that looks like the study drug, but contains no medication. Aspirin or placebo will be taken daily for 5 years. People who were recommended hormonal therapy will continue their hormonal therapy as directed.

• Visit www.abctrial.org for more information. • Contact Wendy Loeser, RN with any questions you may have.

Physician
Contact Information

Wendy Loeser RN OCN Clinical Research Dana-Farber Cancer Institute at St. Elizabeth's Medical Center 736 Cambridge St Boston, MA 02135 617-789-3385 Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
The purpose of this study is to determine if aspirin can prevent a recurrence of breast cancer or prevent the spread of breast cancer (metastatic breast cancer). Recent studies around the world have linked aspirin with a lower risk of death from cancer. This ABC Trial is the first U.S. study to test whether aspirin will keep breast cancer from recurring and reduce death from breast cancer.
Phase
3
Ignore this field in update
Off
Eligibility

• Women or men with node positive, HER2 negative, stage II or III breast carcinoma within one year of diagnosis and free of recurrence. •If any chemotherapy and/or endocrine therapy the last dose must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed. • Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. •Participants will be encouraged to use acetaminophen for minor pain and fever. •Patients must be enrolled within 1 year after diagnosis. •Age > 18 and < 70 years of age. •Platelet count ≥ 100,000/mm3 Exclusions: •No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention. • No history of any prior stroke • No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors. • No history of atrial fibrillation or myocardial infarction. • No history of grade 4 hypertension. •No chronic (duration >30 days) daily use of oral steriods. • No known allergy to aspirin. • No other cancer of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.