Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT02308085
• Date of registration: 21/11/2014
• Prospective Registration: Yes
• Primary sponsor: ETOP IBCSG Partners Foundation
• Public title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer POSITIVE
• Scientific title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy
• Date of first enrolment: December 4, 2014
• Target sample size: 518
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02308085
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Australia, Austria, Belgium, Canada, Denmark, Former Serbia and Montenegro, France, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Netherlands, Norway, Portugal, Serbia, Slovenia, Spain, Switzerland, United States

Contacts

• Name: Olivia Pagani, MD
• Affiliation: Oncology Institue of Southern Switzerland (IOSI)

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial
and patients who have received pharmaco-prevention are eligible.

- The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.

- Patient wishes to become pregnant. Note: Patients who have undergone
oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a
previous history of assisted reproductive technology (ART) are eligible.

- 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.

Note:

- Patients with synchronous bilateral invasive breast cancer (diagnosed histologically
within 2 months) are eligible.

- Patient with invasive breast cancer or synchronous bilateral invasive breast cancer
(diagnosed histologically within 2 months) during pregnancy are eligible.

- Patients with BRCA1/2 mutations are eligible.

- Patients could have received neo/adjuvant chemotherapy, or other systemic therapy
(e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and
patient's desire.

- Patient must be premenopausal at breast cancer diagnosis, as determined locally and
documented in patient record.

- 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.

Exclusion Criteria:

- Post-menopausal patients at BC diagnosis, as determined locally.

- History of hysterectomy, bilateral oophorectomy or ovarian irradiation.

- Patients with current local, loco-regional relapse and/or distant metastatic breast
cancer.

- Patients with a history of prior (ipsi- and/or contralateral) invasive BC.

- 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.

- 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.

- Patients with a history of noncompliance to medical treatments and/or considered
potentially unreliable.

- Patients with psychiatric, addictive, or any disorder that would prevent compliance
with protocol requirements.



Age minimum: 18 Years
Age maximum: 42 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Early Breast Cancer

Intervention(s)

Other: Endocrine therapy interruption

Primary Outcome(s)

Breast Cancer free interval (BCFI) [Time Frame: From enrollment until the first invasive BC event, assessed up to 14 years]

Secondary Outcome(s)

Distant recurrence-free interval (DRFI) [Time Frame: Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years]

Information on Menstruation recovery and pattern [Time Frame: Up to 24 months after enrollment]

Pregnancy rate (determined by pregnancy test) [Time Frame: Up to 24 months after enrollment]

Offspring outcome [Time Frame: Up to 33 months after enrollment]

Use of assisted reproductive Technology (ART) [Time Frame: Up to 24 months after enrollment]

Breastfeeding pattern [Time Frame: Up to 36 months after enrollment]

Pregnancy outcome [Time Frame: Up to 33 months after enrollment]

Secondary ID(s)

IBCSG 48-14 / BIG 8-13

Alliance A221405

NCIC CTG MAC.18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Breast International Group

Alliance for Clinical Trials in Oncology

Canadian Cancer Trials Group