NCI Community Oncology Research Program - Protocol Summary
Alliance A221405 - "A STUDY EVALUATING THE PREGNANCY OUTCOMES AND SAFETY OF INTERRUPTING ENDOCRINE THERAPY FOR YOUNG WOMEN WITH ENDOCRINE RESPONSIVE BREAST CANCER WHO DESIRE PREGNANCY (POSITIVE)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: Breast
RESEARCH BASE: Alliance
NCT NUMBER: NCT02308085
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Patient Brochure: VIEW PATIENT BROCHURE
UPDATED ON 07/27/2018 (16:45:32)
Cancer control, pregnancy outcomes, stage I-III, ER+ and/or PR+ breast ca, endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months, up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive. DCP-001 Eligible
1 FFPE block from primary tumor (at least 5mm invasive tumor and a minor component of normal breast tissue) must be submitted for central review within 4 weeks after enrollment.
Plasma for ctDNA and whole blood for germline analysis must be submitted within 1 month after enrollment.
- Age ≥ 18 and ≤ 42 years at enrollment.
- Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer.
- The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
- Patient wishes to become pregnant.
- Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent.
- Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record. (Note: It is understood that patients’ menopausal status may be unclear at the time of study enrollment.)
- Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record.
- Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment.
- Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial.
- The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
- Patient must be accessible for follow-up.
- No Post-menopausal patients at BC diagnosis, as determined locally.
- No History of hysterectomy, bilateral oophorectomy or ovarian irradiation.
- No Patients with current local, loco-regional relapse and/or distant metastatic breast cancer.
- No Patients with a history of prior (ipsi- and/or contralateral) invasive BC.
- No Patients with previous or concomitant non-breast invasive malignancy. Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix.
- No Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety.
- No Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable.
- No Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.