A Study of Rucaparib Administered With Radiation in Patie... | NCT03542175

ID	Type	Description	Link
P50CA247749	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
Clovis Oncology, Inc.	INDUSTRY
National Cancer Institute (NCI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rucaparib Administered With Radiation	Experimental	one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	Drug: Rucaparib Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rucaparib	Drug	one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.

Measure	Description	Time Frame
Dose Limiting Toxicities	Number of Dose Limiting Toxicities encountered at each dose level. The trial will be monitored using TITE-CRM. Assuming a model for the time to occurrence of toxic response as a function of dose, the method allows information from all enrolled patients to be used when allocating a new patient to a dose level.	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, ≥ 18 years of age.
Non-metastatic, histologically or cytologically-confirmed TNBC (defined as ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative or as per MD discretion), with evidence of residual disease in the breast or lymph nodes after neoadjuvant chemotherapy, at the time of definitive surgical treatment.
Non-metastatic, histologically or cytologically-confirmed hormone-receptor positive, Her2/neu negative breast cancer (defined as ER >1% or PR >1% AND Her-2/neu 0-1+ by IHC or FISH-negative, or as per MD discretion), with evidence of residual grade 3 invasive breast cancer AND either 1) >5 cm of residual disease in the breast OR 2) ≥ 4 axillary LNs in the axilla after neoadjuvant chemotherapy, at the time of definitive surgical treatment.
Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
At least 6-month life expectancy, ECOG Performance status < 2.
Willingness to discontinue any cytotoxic chemotherapeutic agents, and biologic therapy at least 2 weeks prior to the start of RT.
Adequate organ function (assessed within 30 days prior to initiation of protocol treatment, unless otherwise indicated) as follows:

Hematology

Absolute Neutrophil Count (ANC) ≥1500/mm^3
Platelet Count ≥100,000/mm^3
Hemoglobin ≥9.0 g/dL (after transfusion if required) Renal Function
Creatinine Serum ≤ 1.5 mg/dL or Creatinine Clearance ≥ 45 mL/min^a Hepatic Function
Bilirubin ≤ 1.5 mg/dL
Aspartate Aminotransferase (AST) ≤ 2.5 x ULN^b
Alanine Aminotransferase (ALT) ≤ 2.5 x ULN ULN = upper normal limit of institution's normal range
1. If calculated creatinine clearance is < 45mL/min, a 24-hour urine collection for creatinine clearance may be performed
2. Subjects with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL
  - Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  - Ability to swallow and retain oral medications.
  - Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  - Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately.

Exclusion Criteria:

Gross residual tumor on imaging or positive margins after breast conserving surgery that are un-excised, as radiation dose in the study will be limited to 60 Gy.
Complete pathologic response to NAC.
Receipt of PARP inhibitor prior to RT.
Pregnant or expecting to conceive within the projected duration of the trial, starting with screening visit through 180 days after the last dose of trial treatment.
Prior history of radiation therapy to the ipsilateral breast and/or regional nodes is not allowed (prior RT to other sites is permitted).
Patients with breast augmentation implants are excluded.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to rucaparib.
Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosphonates are permitted without restriction even during protocol treatment. Maintenance pembrolizumab is permitted during the protocol treatment.
Significant comorbidity: Patients with clinically significant and uncontrolled major disease or disorder that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit study compliance.
Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
Unresolved toxicity from other agents. Patients with unresolved CTCAE v4.03 Grade 3 or greater toxicity from prior administration of another investigational drug and/or anti-cancer treatment are not eligible.

Name	Affiliation	Role
Atif Khan, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Norwalk Hospital		Norwalk	Connecticut	06850	United States
Memorial Sloan Kettering at Basking Ridge

Label	URL
Memorial Sloan Kettering Cancer Center	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rucaparib 200 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 2, 2022

Arm/Group Information

ID	Title	Description
BG000	Rucaparib 200 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
BG001	Rucaparib 200 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
BG002	Rucaparib 300 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
BG003	Rucaparib 300 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
BG004	Rucaparib 400 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG0002 BG0016 BG0025 BG00316 BG0042 BG00531

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dose Limiting Toxicities

Number of Dose Limiting Toxicities encountered at each dose level. The trial will be monitored using TITE-CRM. Assuming a model for the time to occurrence of toxic response as a function of dose, the method allows information from all enrolled patients to be used when allocating a new patient to a dose level.

Posted

Number

Dose limiting toxicities

1 year

ID	Title	Description
OG000	Rucaparib 200 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
OG001	Rucaparib 200 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
OG002	Rucaparib 300 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
OG003	Rucaparib 300 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
OG004	Rucaparib 400 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.

Units	Counts
Participants	OG0002 OG0016 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010 OG0023 OG003

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rucaparib 200 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	1	2	0	2	2	2
EG001	Rucaparib 200 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	2	6	1	6	6	6
EG002	Rucaparib 300 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	0	5	0	5	5	5
EG003	Rucaparib 300 mg QD	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	4	16	1	16	16	16
EG004	Rucaparib 400 mg BID	Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level. Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.	0	2	0	2	2	2

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Adrenal insufficiency	Endocrine disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG0030 affected16 at risk EG0040 affected2 at risk
Aguesia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Breast atrophy	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dermatitis radiation	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected2 at risk EG0014 affected6 at risk EG0023 affected5 at risk EG003
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Eye infection	Infections and infestations	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected2 at risk EG0013 affected6 at risk EG0020 affected5 at risk EG003
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Left chest wall tightness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Left rotator cuff tear	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Lymphedema	Vascular disorders	Systematic Assessment	EG0001 affected2 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Moist Desquamation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Neutrophil count decreased	Investigations	Systematic Assessment	EG0001 affected2 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Olfactory nerve disorder	Nervous system disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Pain	General disorders	Systematic Assessment	EG0000 affected2 at risk EG0013 affected6 at risk EG0020 affected5 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Radiation skin reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Receding gum lower center jaw	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Seborrheic dermatitis (scalp)	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Shingles	Infections and infestations	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Skin infection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected2 at risk EG0012 affected6 at risk EG0020 affected5 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Weight loss	Investigations	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
White blood cell decreased	Investigations	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003

ID	Term
D001943	Breast Neoplasms
D064726	Triple Negative Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaphylaxis	Immune system disorders		Systematic Assessment		EG0000 affected2 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG0031 affected16 at risk EG0040 affected2 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders		Systematic Assessment		EG0000 affected2 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003