ID

38060

Description

Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01530607

Link

https://clinicaltrials.gov/show/NCT01530607

Keywords

Versions (1)
  1. 9/13/19 9/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01530607

English

Eligibility Breast Cancer NCT01530607

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must be premenopausal women with a histologically confirmed diagnosis of operable stage i, ii, or iiia invasive breast cancer. patients who have completed surgery must have pathologic stage i, ii, or iiia disease. patients to be treated in the preoperative setting may be staged clinically but must have operable disease. for the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of fsh and estradiol levels in the premenopausal range.
Description

Premenopausal state | Invasive carcinoma of breast Operable TNM Breast tumor staging | Operative Surgical Procedure Completed | Disease Pathologic TNM stage | Follicle stimulating hormone measurement Consistent with Premenopausal state | Estradiol measurement Consistent with Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1319019
UMLS CUI [5,1]
C0202022
UMLS CUI [5,2]
C0332290
UMLS CUI [5,3]
C0232969
UMLS CUI [6,1]
C0337434
UMLS CUI [6,2]
C0332290
UMLS CUI [6,3]
C0232969
2. patients must have tumors that are both estrogen receptor negative and progesterone receptor negative.
Description

Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2584629
UMLS CUI [2]
C2584628
3. patients must be of age 18 or greater and under age 50.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. the patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
Description

Therapeutic procedure Planned Duration | Chemotherapy cycles Alkylating Agents Postoperative | Chemotherapy cycles Alkylating Agents Preoperative | Chemotherapy Regimen Anthracycline Based | Chemotherapy Regimen Without Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0002073
UMLS CUI [2,3]
C0032790
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C0002073
UMLS CUI [3,3]
C0445204
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0282564
UMLS CUI [4,3]
C1705938
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332288
UMLS CUI [5,3]
C0282564
5. for patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting
Description

Chemotherapy Preoperative | Absence Chemotherapy Additional Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0445204
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1524062
UMLS CUI [2,4]
C0032790
6. patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.
Description

Enrollment Chemotherapy Postoperative | Status post Operative Surgical Procedure Primary tumor | Status post Operative Surgical Procedure Axilla

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0032790
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0677930
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0004454
7. patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition. patients currently enrolled on s0221 are eligible for this study.
Description

Cytotoxic Chemotherapy Absent Breast Carcinoma | Cytotoxic Chemotherapy Any Absent | Enrollment Clinical Trial Specified allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1552551
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0205369
UMLS CUI [3,4]
C0683607
8. patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. in addition, for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization.
Description

Estrogens Absent | Estrogen Antagonists Absent | Selective Estrogen Receptor Modulators Absent | Aromatase Inhibitors Absent | Hormonal contraception Absent | Oral Contraceptives To be stopped | Hormone Therapy Oocyte Retrieval Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0014939
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0014930
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0732611
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0593802
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C2985296
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0009905
UMLS CUI [6,2]
C1272691
UMLS CUI [7,1]
C0279025
UMLS CUI [7,2]
C0404268
UMLS CUI [7,3]
C0205197
women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation of fsh and estradiol levels in the premenopausal range.
Description

Use of Oral Contraceptives | Hormone Therapy Oocyte Retrieval | Follicle stimulating hormone measurement Consistent with Premenopausal state | Estradiol measurement Consistent with Premenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0009905
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0404268
UMLS CUI [3,1]
C0202022
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0232969
UMLS CUI [4,1]
C0337434
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C0232969
9. no prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been diseasefree for five years after treatment with curative intent.
Description

Malignant Neoplasms Excluded | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ Treated | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007099
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
10. patients must have a performance status of 0 - 2 by zubrod criteria (see section 10.4).
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
11. pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential must agree to use an effective barrier contraceptive method.
Description

Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0004764
13. all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Breast Cancer NCT01530607

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Premenopausal state | Invasive carcinoma of breast Operable TNM Breast tumor staging | Operative Surgical Procedure Completed | Disease Pathologic TNM stage | Follicle stimulating hormone measurement Consistent with Premenopausal state | Estradiol measurement Consistent with Premenopausal state
Item
1. patients must be premenopausal women with a histologically confirmed diagnosis of operable stage i, ii, or iiia invasive breast cancer. patients who have completed surgery must have pathologic stage i, ii, or iiia disease. patients to be treated in the preoperative setting may be staged clinically but must have operable disease. for the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of fsh and estradiol levels in the premenopausal range.
boolean
C0232969 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C1319019 (UMLS CUI [4,2])
C0202022 (UMLS CUI [5,1])
C0332290 (UMLS CUI [5,2])
C0232969 (UMLS CUI [5,3])
C0337434 (UMLS CUI [6,1])
C0332290 (UMLS CUI [6,2])
C0232969 (UMLS CUI [6,3])
Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm
Item
2. patients must have tumors that are both estrogen receptor negative and progesterone receptor negative.
boolean
C2584629 (UMLS CUI [1])
C2584628 (UMLS CUI [2])
Age
Item
3. patients must be of age 18 or greater and under age 50.
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Planned Duration | Chemotherapy cycles Alkylating Agents Postoperative | Chemotherapy cycles Alkylating Agents Preoperative | Chemotherapy Regimen Anthracycline Based | Chemotherapy Regimen Without Anthracyclines
Item
4. the patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C0002073 (UMLS CUI [2,2])
C0032790 (UMLS CUI [2,3])
C1302181 (UMLS CUI [3,1])
C0002073 (UMLS CUI [3,2])
C0445204 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0282564 (UMLS CUI [4,2])
C1705938 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5,1])
C0332288 (UMLS CUI [5,2])
C0282564 (UMLS CUI [5,3])
Chemotherapy Preoperative | Absence Chemotherapy Additional Postoperative
Item
5. for patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting
boolean
C0392920 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
C0032790 (UMLS CUI [2,4])
Enrollment Chemotherapy Postoperative | Status post Operative Surgical Procedure Primary tumor | Status post Operative Surgical Procedure Axilla
Item
6. patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.
boolean
C1516879 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0677930 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0004454 (UMLS CUI [3,3])
Cytotoxic Chemotherapy Absent Breast Carcinoma | Cytotoxic Chemotherapy Any Absent | Enrollment Clinical Trial Specified allowed
Item
7. patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition. patients currently enrolled on s0221 are eligible for this study.
boolean
C0677881 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1516879 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
Estrogens Absent | Estrogen Antagonists Absent | Selective Estrogen Receptor Modulators Absent | Aromatase Inhibitors Absent | Hormonal contraception Absent | Oral Contraceptives To be stopped | Hormone Therapy Oocyte Retrieval Completed
Item
8. patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. in addition, for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization.
boolean
C0014939 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0014930 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0732611 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0593802 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0009905 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
C0279025 (UMLS CUI [7,1])
C0404268 (UMLS CUI [7,2])
C0205197 (UMLS CUI [7,3])
Use of Oral Contraceptives | Hormone Therapy Oocyte Retrieval | Follicle stimulating hormone measurement Consistent with Premenopausal state | Estradiol measurement Consistent with Premenopausal state
Item
women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation of fsh and estradiol levels in the premenopausal range.
boolean
C1524063 (UMLS CUI [1,1])
C0009905 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0404268 (UMLS CUI [2,2])
C0202022 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0232969 (UMLS CUI [3,3])
C0337434 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0232969 (UMLS CUI [4,3])
Malignant Neoplasms Excluded | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ Treated | Exception Disease Free Duration
Item
9. no prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been diseasefree for five years after treatment with curative intent.
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Zubrod Performance Status
Item
10. patients must have a performance status of 0 - 2 by zubrod criteria (see section 10.4).
boolean
C3714786 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception
Item
11. pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential must agree to use an effective barrier contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
Informed Consent
Item
13. all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
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