Arm Name	Arm Description
Breast cancer patients


Follow-up period
Comments


	Korea


	Randomized Controlled study Pooled analysis of RCTs Prospective cohosrt study retrospective cohosrt study Registry-based Single-center Multicenter Nationalwide Other (please, indicate) Not reported


	"patients with breast cancer who had been treated with mastectomy (including simple, subcutaneous, partial, or curative resection [including modified radical mastectomy and curative breast conservation]; N7131, N7132, N7133, N7135), and treated with AC and/ or T."


	prior CHF history


Is protocol for the study available in public registries?
Comments (Registry number, etc)


	2007-2016


	Yes No

Sample Characteristics

1. Sample size

Please, provide the sample size of total breast cancer population

Breast cancer patients

2. Age

If it is reported only for different study groups, overall mean age  could be calculated easily with the following link - https://www.statstodo.com/CombineMeansSDs.php (Javascript Program)

Breast cancer patients


Mean age of the population
standard deviation
% of different age categories
Comments

3. Males (percentage)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Males (percentage)
Comments

4. Percentage of patients with postmenopausal status

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	N/A

5. Race

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


White (Caucasian)
Hispanic
African–American (Black)
Asian
Comments

6. History of ischemic heart disease (percentage)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


percentage
Comments

7. History of cardiac disease

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	N/A

8. History of diabetes (percentage)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

9. Hypertension

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

10. Smoking

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

11. Alcohol

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

12. Dyslipidemia (if not reported - use of lipid-lowering therapy)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

13. Atrial fibrillation

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

14. Prior myocardial infarction (baseline characteristics)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

15. Previous heart failure

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

16. Previous stroke

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

17. Peripheral artery disease

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments	n/a

18. Valvular heart disease

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

19. Abnormal renal function

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

20. Charlson Comorbidity Index

Breast cancer patients


Mean value
percentage for different categories

21. History of hormonal replacement therapy (percentage)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Percentage
Comments

22. Body mass index (mean value)

If it is reported only for different study groups, overall mean value and deviation could be calculated easily with the following link - https://www.statstodo.com/CombineMeansSDs.php (Javascript Program)

Breast cancer patients


Mean value
Standard deviation
Overweight percentage
Comments

23. Breast cancer stage (percentage)

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Stage 0 (ductal carcinoma in situ)/ local
Stage I (local)
Stage II (regional)
Stage III (regional)
Stage IV (distant/metastatic)
Local/Regional/distant
Comments

24. Tumor differentiation grade

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Good - 1
Moderate - 2
Poor - 3
Comments

25. Type of breast cancer

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Estrogen receptor positive
Progesteron receptor positive
Her2 positive
Triple negative
Any hormon receptor positive
Comments

26. Axillary lymph node status

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


negative
positive
comments

27. Laterality of breast cancer

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Left-sided
Right-sided
Both sides
Comments

28. Size of breast tumor

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


< 2 cm
2-5 cm
> 5 cm
Comments

29. Type of surgical treatment

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Surgery (percentage)
Mastectomy
Breast-conserving surgery
Ovarian ablation
axillary lymph node dissection
Comments

30. Anti-cancer systemic treatment

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Adjuvant systemic treatment (after surgery), %
Neoadjuvant systemic treatment (before surgery), %
Any endocrine/hormonal therapy (tamoxifen/aromotase inhibitor), %
Tamoxifen use, %
Other aromatase inhibitor use, %
Chemotherapy (antracycline/taxane/cyclophosphamide based), %
Antracycline use, %
Any Anti-HER2 therapy (Trastuzumab/pertuzumab/neratinib/etc)
Trastuzumab use, %
Comments

31. Radiation therapy

Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups

Breast cancer patients


Adjuvant radiotherapy, %
Total radiation dose (mean)
Moderate hypofractionation schedules, %
Techniques
Comments

		Descriptive Statistics		Between Arm Comparisons
		Breast cancer patients
long-term follow-up
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Breast cancer patients


Method o assessment	National Death Registry Clinical follow-up visits Telephone interviews Questionnaire, outcomes were self-reported by patients Medical records Electronic Health Record System Other methods (please specify) Not reported
Comments

Extraction form for project: Breast cancer and cardiovascular outcomes

Design Details

Arms

Arm Details

1. Follow-up period

2. Country

3. Study design

4. Key inclusion criteria

5. Key exclusion criteria

6. Is protocol for the study available in public registries?

7. Recruitment period

8. SEER based study?

Sample Characteristics

1. Sample size

Breast cancer patients

2. Age

Breast cancer patients

3. Males (percentage)

Breast cancer patients

4. Percentage of patients with postmenopausal status

Breast cancer patients

5. Race

Breast cancer patients

6. History of ischemic heart disease (percentage)

Breast cancer patients

7. History of cardiac disease

Breast cancer patients

8. History of diabetes (percentage)

Breast cancer patients

9. Hypertension

Breast cancer patients

10. Smoking

Breast cancer patients

11. Alcohol

Breast cancer patients

12. Dyslipidemia (if not reported - use of lipid-lowering therapy)

Breast cancer patients

13. Atrial fibrillation

Breast cancer patients

14. Prior myocardial infarction (baseline characteristics)

Breast cancer patients

15. Previous heart failure

Breast cancer patients

16. Previous stroke

Breast cancer patients

17. Peripheral artery disease

Breast cancer patients

18. Valvular heart disease

Breast cancer patients

19. Abnormal renal function

Breast cancer patients

20. Charlson Comorbidity Index

Breast cancer patients

21. History of hormonal replacement therapy (percentage)

Breast cancer patients

22. Body mass index (mean value)

Breast cancer patients

23. Breast cancer stage (percentage)

Breast cancer patients

24. Tumor differentiation grade

Breast cancer patients

25. Type of breast cancer

Breast cancer patients

26. Axillary lymph node status

Breast cancer patients

27. Laterality of breast cancer

Breast cancer patients

28. Size of breast tumor

Breast cancer patients

29. Type of surgical treatment

Breast cancer patients

30. Anti-cancer systemic treatment

Breast cancer patients

31. Radiation therapy

Breast cancer patients

Outcomes

Outcome Details

1. What is the definitions for the particular outcome?

Symptomatic heart failure incidence

2. How were outcomes assessed?