Aspirin for Node Positive HER2 Negative Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Kaiser Permanente-Redwood City, Redwood City, CA
Node Positive HER2 Negative Breast Cancer+1 More
Aspirin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether aspirin might prevent cancer recurrence in patients with breast cancer.

See full description

Eligible Conditions

  • Node Positive HER2 Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Node Positive HER2 Negative Breast Cancer

Study Objectives

This trial is evaluating whether Aspirin will improve 1 primary outcome and 4 secondary outcomes in patients with Node Positive HER2 Negative Breast Cancer. Measurement will happen over the course of Time from randomization to first occurrence of any one of the following: distant recurrence, locoregional recurrence, ipsilateral or contralateral breast cancer, second primary (non-breast) invasive cancer or death or any cause, assessed up to 5 years.

Year 5
Invasive disease-free survival (iDFS)
Year 5
Distant disease free survival (DDFS)
Up to 5 years
Incidence of cardiovascular disease (including cerebrovascular events, myocardial infarction, or coronary artery disease requiring stent placement, angioplasty, or bypass surgery)
Incidence of toxicities, graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.3
Year 5
Overall survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Node Positive HER2 Negative Breast Cancer

Side Effects for

PROMUS Element
ANGINA PECTORIS
4%
ANGINA UNSTABLE
3%
NON-CARDIAC CHEST PAIN
3%
CORONARY ARTERY DISEASE
2%
CARDIAC FAILURE CONGESTIVE
2%
ACUTE MYOCARDIAL INFARCTION
1%
ATRIAL FIBRILLATION
1%
CORONARY ARTERY DISSECTION
1%
PNEUMONIA
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
CORONARY ARTERY THROMBOSIS
1%
GASTROINTESTINAL HAEMORRHAGE
1%
DYSPNOEA
1%
SYNCOPE
1%
MYOCARDIAL INFARCTION
1%
MALAISE
0%
IMPAIRED GASTRIC EMPTYING
0%
HYPERTROPHIC CARDIOMYOPATHY
0%
BLADDER CANCER
0%
DRUG TOXICITY
0%
PAIN IN EXTREMITY
0%
BLOOD CREATININE INCREASED
0%
PULMONARY FIBROSIS
0%
DIVERTICULITIS
0%
VENTRICULAR FIBRILLATION
0%
BRONCHITIS
0%
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
0%
LUNG INFILTRATION
0%
TAKAYASU'S ARTERITIS
0%
SMALL INTESTINAL OBSTRUCTION
0%
HYPOAESTHESIA
0%
SCIATICA
0%
HYPERTENSIVE CRISIS
0%
CONTRAST MEDIA REACTION
0%
URINARY RETENTION
0%
SPINAL COLUMN STENOSIS
0%
DIABETIC KETOACIDOSIS
0%
POSTINFARCTION ANGINA
0%
THROMBOPHLEBITIS
0%
SPONTANEOUS HAEMATOMA
0%
CARDIOGENIC SHOCK
0%
GASTRIC DISORDER
0%
HAEMATOCHEZIA
0%
DIVERTICULITIS MECKEL'S
0%
DIABETIC GASTROPARESIS
0%
RETROPERITONEAL HAEMORRHAGE
0%
BONE PAIN
0%
TRANSIENT ISCHAEMIC ATTACK
0%
SARCOMA METASTATIC
0%
FLUID OVERLOAD
0%
CALCULUS URETERIC
0%
MYOCARDIAL ISCHAEMIA
0%
COLITIS ISCHAEMIC
0%
MITRAL VALVE INCOMPETENCE
0%
PALPITATIONS
0%
CATHETERISATION CARDIAC
0%
ANAL FISTULA
0%
LYMPHOMA
0%
BREAST CANCER
0%
PARAESTHESIA
0%
OESOPHAGEAL CARCINOMA
0%
ACCELERATED HYPERTENSION
0%
VASCULAR GRAFT COMPLICATION
0%
NEPHROLITHIASIS
0%
NON-SMALL CELL LUNG CANCER STAGE IV
0%
MICROCYTIC ANAEMIA
0%
PAIN IN JAW
0%
HYPERGLYCAEMIA
0%
CHOLANGITIS
0%
ANGIOEDEMA
0%
ODYNOPHAGIA
0%
WOUND
0%
HYPERKALAEMIA
0%
CHOLECYSTITIS
0%
THROMBOCYTOPENIA
0%
COUGH
0%
LOSS OF CONSCIOUSNESS
0%
DRUG HYPERSENSITIVITY
0%
CEREBRAL HAEMORRHAGE
0%
DEEP VEIN THROMBOSIS
0%
INTERMITTENT CLAUDICATION
0%
BONE MARROW FAILURE
0%
RENAL FAILURE ACUTE
0%
PROSTATE CANCER
0%
RENAL COLIC
0%
SEPTIC SHOCK
0%
ANKLE FRACTURE
0%
B-CELL LYMPHOMA
0%
PANCREATIC CARCINOMA
0%
ENCEPHALOPATHY
0%
CONVULSION
0%
BRAIN STEM STROKE
0%
BRONCHITIS VIRAL
0%
PULMONARY EMBOLISM
0%
LETHARGY
0%
PULMONARY HYPERTENSION
0%
ATRIOVENTRICULAR BLOCK COMPLETE
0%
URINARY TRACT INFECTION
0%
DYSPHAGIA
0%
ASTHMA
0%
INGUINAL HERNIA
0%
HAEMATOMA
0%
EPISTAXIS
0%
ALLERGIC BRONCHITIS
0%
FEMORAL ARTERY OCCLUSION
0%
PROCEDURAL HYPERTENSION
0%
RENAL DISORDER
0%
ANAEMIA
0%
BRONCHIAL CARCINOMA
0%
LUNG CANCER METASTATIC
0%
MALIGNANT MELANOMA
0%
HAEMORRHAGIC ANAEMIA
0%
PROSTATE CANCER METASTATIC
0%
IRON DEFICIENCY ANAEMIA
0%
COSTOCHONDRITIS
0%
OBESITY
0%
DIABETIC FOOT
0%
POSTMENOPAUSAL HAEMORRHAGE
0%
GASTROOESOPHAGEAL REFLUX DISEASE
0%
CARPAL TUNNEL SYNDROME
0%
ADENOCARCINOMA PANCREAS
0%
GASTRITIS EROSIVE
0%
RETROPERITONEAL HAEMATOMA
0%
RADICULAR PAIN
0%
GASTRIC CANCER
0%
CARDIAC FAILURE CHRONIC
0%
DEATH
0%
POSTOPERATIVE WOUND INFECTION
0%
ARTHRALGIA
0%
CORONARY ARTERY OCCLUSION
0%
GASTRITIS
0%
ANOGENITAL WARTS
0%
FACIAL BONES FRACTURE
0%
FLANK PAIN
0%
BIPOLAR DISORDER
0%
AORTIC STENOSIS
0%
LYMPHOEDEMA
0%
POSTOPERATIVE WOUND COMPLICATION
0%
SARCOMA
0%
METASTATIC GASTRIC CANCER
0%
BLOOD GLUCOSE DECREASED
0%
HYPERSENSITIVITY
0%
CARDIOMYOPATHY
0%
APPENDICITIS
0%
PNEUMONITIS
0%
DEHYDRATION
0%
RENAL ARTERY STENOSIS
0%
VENTRICULAR TACHYCARDIA
0%
CHEST PAIN
0%
GASTRIC ULCER
0%
ANXIETY
0%
INTESTINAL POLYP
0%
ARTERIOSCLEROSIS
0%
RIB FRACTURE
0%
ENDOMETRIAL CANCER
0%
CHOLECYSTITIS ACUTE
0%
GALLBLADDER DISORDER
0%
BLADDER OBSTRUCTION
0%
RENAL TUBULAR NECROSIS
0%
ISCHAEMIC HEPATITIS
0%
ISCHAEMIC CARDIOMYOPATHY
0%
INFECTION
0%
ABDOMINAL HERNIA
0%
STREPTOCOCCAL BACTERAEMIA
0%
CHOLELITHIASIS
0%
ENCEPHALITIS
0%
VENOUS THROMBOSIS LIMB
0%
RENAL FAILURE
0%
URETHRAL STENOSIS
0%
FEBRILE NEUTROPENIA
0%
VERTIGO
0%
SUBARACHNOID HAEMORRHAGE
0%
DYSPNOEA EXERTIONAL
0%
PERIPHERAL COLDNESS
0%
PERIPHERAL ISCHAEMIA
0%
MALIGNANT HYPERTENSION
0%
DISLOCATION OF JOINT PROSTHESIS
0%
ACUTE CORONARY SYNDROME
0%
CARDIAC FAILURE
0%
BACTERAEMIA
0%
INTESTINAL HAEMORRHAGE
0%
CORONARY ARTERY STENOSIS
0%
OSTEOMYELITIS
0%
CATHETER SITE HAEMATOMA
0%
CORONARY ARTERY EMBOLISM
0%
CAROTID ARTERY DISEASE
0%
PELVIC FRACTURE
0%
STAPHYLOCOCCAL INFECTION
0%
BLOODY DISCHARGE
0%
ANASTOMOTIC ULCER HAEMORRHAGE
0%
HYPOXIA
0%
ALCOHOL POISONING
0%
PNEUMONIA ASPIRATION
0%
OESOPHAGEAL ULCER
0%
AORTIC ANEURYSM
0%
TIBIA FRACTURE
0%
CARDIO-RESPIRATORY ARREST
0%
ULCER HAEMORRHAGE
0%
ATRIAL FLUTTER
0%
GRAFT THROMBOSIS
0%
HAEMATURIA
0%
LOWER GASTROINTESTINAL HAEMORRHAGE
0%
SEROMA
0%
WOUND DEHISCENCE
0%
DIARRHOEA
0%
THORACIC VERTEBRAL FRACTURE
0%
BASAL GANGLIA INFARCTION
0%
TRAUMATIC BRAIN INJURY
0%
GUN SHOT WOUND
0%
URETHRAL MEATUS STENOSIS
0%
POST PROCEDURAL COMPLICATION
0%
FALL
0%
PANCREATITIS ACUTE
0%
FEMUR FRACTURE
0%
DELIRIUM
0%
NAUSEA
0%
HYPERTENSION
0%
HYPOTENSION
0%
CONVERSION DISORDER
0%
PUBIC RAMI FRACTURE
0%
BENIGN NEOPLASM
0%
COLON CANCER
0%
BILIARY DYSKINESIA
0%
TUMOUR HAEMORRHAGE
0%
CATARACT
0%
HEPATIC CIRRHOSIS
0%
HEADACHE
0%
HYPOKALAEMIA
0%
PERIPHERAL VASCULAR DISORDER
0%
DUODENAL ULCER
0%
DYSLIPIDAEMIA
0%
DEPRESSION
0%
LUNG NEOPLASM
0%
Myocardial Infarction
0%
CAROTID ENDARTERECTOMY
0%
SYNOVIAL CYST
0%
MYCOBACTERIAL INFECTION
0%
RENAL FAILURE CHRONIC
0%
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
0%
HYPONATRAEMIA
0%
ARTHRITIS
0%
DIABETES MELLITUS
0%
PROSTATITIS
0%
INFLUENZA LIKE ILLNESS
0%
PAIN
0%
WOUND INFECTION
0%
COLITIS
0%
CARDIAC ARREST
0%
TACHYCARDIA
0%
AORTIC VALVE STENOSIS
0%
HERNIA
0%
SINUS BRADYCARDIA
0%
ATRIOVENTRICULAR BLOCK SECOND DEGREE
0%
OEDEMA PERIPHERAL
0%
ABSCESS LIMB
0%
MELAENA
0%
PYREXIA
0%
CELLULITIS
0%
CHEST DISCOMFORT
0%
IMPAIRED HEALING
0%
MEDIASTINAL MASS
0%
BRADYCARDIA
0%
TACHYARRHYTHMIA
0%
ADVERSE EVENT
0%
ASTHENIA
0%
UROSEPSIS
0%
ACUTE RESPIRATORY FAILURE
0%
SINUS ARRHYTHMIA
0%
RESPIRATORY TRACT INFECTION
0%
ABDOMINAL PAIN UPPER
0%
ARRHYTHMIA
0%
BUNDLE BRANCH BLOCK LEFT
0%
SICK SINUS SYNDROME
0%
SEPSIS
0%
GANGRENE
0%
PNEUMONIA BACTERIAL
0%
PNEUMOTHORAX
0%
PULMONARY OEDEMA
0%
PLEURAL EFFUSION
0%
GASTROENTERITIS VIRAL
0%
LOBAR PNEUMONIA
0%
ABDOMINAL ABSCESS
0%
ENDOCARDITIS BACTERIAL
0%
CLOSTRIDIAL INFECTION
0%
GASTROENTERITIS
0%
PNEUMONIA STAPHYLOCOCCAL
0%
INFLUENZA
0%
BRONCHIECTASIS
0%
PYELONEPHRITIS
0%
OSTEOMYELITIS CHRONIC
0%
ACUTE PULMONARY OEDEMA
0%
CHRONIC RESPIRATORY FAILURE
0%
OSTEOMYELITIS ACUTE
0%
RESPIRATORY FAILURE
0%
PURULENT DISCHARGE
0%
GASTRIC HAEMORRHAGE
0%
RECTAL HAEMORRHAGE
0%
CAROTID ARTERY STENOSIS
0%
CEREBRAL INFARCTION
0%
PANCREATITIS
0%
ABDOMINAL PAIN
0%
PRESYNCOPE
0%
HAEMOPTYSIS
0%
VOMITING
0%
DYSARTHRIA
0%
UPPER GASTROINTESTINAL HAEMORRHAGE
0%
RESPIRATORY DISTRESS
0%
GASTROINTESTINAL PAIN
0%
SHOCK
0%
CEREBROVASCULAR ACCIDENT
0%
HAEMORRHOIDS
0%
GASTRIC POLYPS
0%
ROAD TRAFFIC ACCIDENT
0%
FEMORAL ARTERY ANEURYSM
0%
HAEMORRHOIDAL HAEMORRHAGE
0%
HIP FRACTURE
0%
INCISIONAL HERNIA
0%
CERVICAL VERTEBRAL FRACTURE
0%
VASCULAR PSEUDOANEURYSM
0%
ORTHOSTATIC HYPOTENSION
0%
PROCEDURAL PAIN
0%
CONCUSSION
0%
GASTROINTESTINAL STOMA COMPLICATION
0%
LUNG NEOPLASM MALIGNANT
0%
LIP AND/OR ORAL CAVITY CANCER
0%
ARTERIAL THROMBOSIS LIMB
0%
ARTERIAL THROMBOSIS
0%
POLYMYALGIA RHEUMATICA
0%
BLOOD URINE
0%
HOT FLUSH
0%
ISCHAEMIC LIMB PAIN
0%
POST PROCEDURAL HAEMORRHAGE
0%
ROTATOR CUFF SYNDROME
0%
ISCHAEMIA
0%
BACK PAIN
0%
MUSCULOSKELETAL DISCOMFORT
0%
PANCYTOPENIA
0%
MUSCULOSKELETAL CHEST PAIN
0%
CERVICAL SPINAL STENOSIS
0%
LUMBAR SPINAL STENOSIS
0%
LEUKOCYTOSIS
0%
OSTEOARTHRITIS
0%
MUSCULOSKELETAL PAIN
0%
SPINAL OSTEOARTHRITIS
0%
CHOLECYSTITIS CHRONIC
0%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT01589978) in the PROMUS Element ARM group. Side effects include: ANGINA PECTORIS with 4%, ANGINA UNSTABLE with 3%, NON-CARDIAC CHEST PAIN with 3%, CORONARY ARTERY DISEASE with 2%, CARDIAC FAILURE CONGESTIVE with 2%.

Trial Design

2 Treatment Groups

Arm I (aspirin)
1 of 2
Arm II (Placebo)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 3021 total participants across 2 different treatment groups

This trial involves 2 different treatments. Aspirin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm I (aspirin)
Drug
Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
Arm II (Placebo)
Other
Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Kaiser Permanente-Redwood City - Redwood City, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility
Any ER/progesterone receptor (PgR) status allowed
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed
Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days 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
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention
No history of any prior stroke (hemorrhagic or ischemic)
No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors

Patient Q&A Section

Can breast cancer be cured?

"Overall, patients are optimistic about their chances of being cured. Patients and their families often want curative treatment, but patients' desire for curative treatment may be motivated to avoid the risks of medical treatment." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The cause of this cancer is unclear. Some environmental, genetic and hormonal factors have been implicated. It may also be a consequence of cancer cells spreading to other parts of the body. There is a possibility that risk is higher among survivors of breast cancer, but no strong evidence for that has been found.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Many people with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) do not have any symptoms at diagnosis. Others may complain of pain in the chest or over the breast. Nipple discharge is often a result of breast cancer, but may also be due to other health problems. A lump in the breast may be a sign of breast cancer. Other signs and symptoms of breast cancer include lump, thickening or dimpling of the nipple, redness or sores around a nipple, lump in the breast that does not disappear or itch.\nSymptoms of testicular cancer involve the formation of a lump near the testicles, swelling around the testicles or pain or numbness in the scrotum." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Breast cancer is often treated with hormone replacement therapy and surgery. Chemotherapy, radiotherapy, and targeted therapy are sometimes used. These treatments can contribute to the cancer's effectiveness." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"The US prevalence of breast cancer is substantially lower than that of other industrialized nations. Because there are several factors that may lead to a delay in the diagnosis of breast cancer, the observed differences in the prevalence of breast cancer between different industrialized nations may be influenced by differences in the proportions of women with risk factors for breast cancer." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a cancer that forms in the breasts and typically forms in women over 50 years of age. Diagnosis is typically made through mammograms undertaken for other reasons. It is the most common type of cancer in women in developed countries, accounting for approximately 25% of all cancers in women." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"New treatments have been developed in recent years that have shown to be more effective but also have several disadvantages in their use for breast cancer treatment. Therefore, the ultimate treatment selection depends on a comprehensive review of the situation of the patient." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The new research has improved treatment options and diagnostic tests for cancers and their precursors. At the same time they have raised questions about diagnosis, prevention and treatment. Even though there is no guarantee that the latest research will improve the 5-year survival, it is sure that there is hope for the future, because of the work being done by the leaders in science and medicine question: Do breast cancer treatment guidelines need to update? answer: Breast cancer has been revised as a disease for a number of years, and this is likely to be the case as more evidence shows that the optimal management is disputed. However there is no indication that this situation will change in the foreseeable future." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"The average age that someone gets [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is 50 years. A little older than average has been reported as 47 yr. It is important to have periodic mammograms and have these tests as early as possible so as to detect cancer when it is manageable and to give the patient options on treatment options." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in aspirin for therapeutic use?

"For breast cancer patients with hormone-resistance, this study suggests that aspirin plus chemo-herbal therapy may provide survival benefit comparable to that of endocrine therapy with tamoxifen alone or chemo-endocrine therapy with tamoxifen/aromatase inhibitor." - Anonymous Online Contributor

Unverified Answer

What does aspirin usually treat?

"Although it is sometimes touted that aspirin prevents both colorectal and [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), in the real world, aspirin’s effectiveness is most commonly associated with preventing colorectal adenomas and cancers. More than 30% of the people taking aspirin to prevent colon cancer will eventually develop cancer. Currently, NSAID only is a preventive or therapeutic option in a very small minority of breast cancer patients. Breast cancer usually does not respond to NSAID-only or chemo-only treatment. The combination of NSAID and chemo usually will cause even more side effects as well as increased risk over time. It may take almost 5 years to see any positive effects with NSAID alone use." - Anonymous Online Contributor

Unverified Answer

Is aspirin typically used in combination with any other treatments?

"Although the use of this medication increased between years 1999 and 2007, there still remain many uncertainties regarding its use in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). This is because it is often used with chemotherapy. Breast cancer patients in this cohort are less likely to be able to obtain benefit from this medications use. The use of aspirin was more common for patients with node-negative cancer. The use of this therapy was also commonly associated with paclitaxel (taxol), a chemotherapy drug being used for breast cancer patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Node Positive HER2 Negative Breast Cancer by sharing your contact details with the study coordinator.